<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03239808</url>
  </required_header>
  <id_info>
    <org_study_id>IHDIP (P1712)</org_study_id>
    <nct_id>NCT03239808</nct_id>
  </id_info>
  <brief_title>Incremental Haemodialysis in Incident Patients</brief_title>
  <acronym>IHDIP</acronym>
  <official_title>Assessment of the Incremental Haemodialysis Security and Effectiveness in Incident Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital San Pedro de Alcantara</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Virgen del Puerto Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Central de la Defensa Gómez Ulla. Madrid (Spain)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Costa del Sol</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Obispo Polanco. Teruel (Spain)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Manises. Valencia (Spain)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Virgen de la Concha. Zamora (Spain)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Especialidades de las Fuerzas Armadas. Quito (Ecuador)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Servicio Extremeño de Salud (Spain)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital del SAS de Jerez</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Nuestra Sra de Sonsoles. Ávila (Spain)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dialysis Center SM2. Potenza (Italy)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Miulli General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital del Río Hortega</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Duran de Buenos Aires</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital El Bierzo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospitales Universitarios Virgen del Rocío</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario Virgen Macarena</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario Dr J Trueta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Incremental hemodialysis (HD) is a starting regime for renal replacement therapy&#xD;
      (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal&#xD;
      function (RRF). The frequency of sessions with which patients start HD -one or two sessions&#xD;
      per week-, is lower than that for conventional HD three times per week. Such frequency is&#xD;
      increased (from one to two sessions, and from two to three sessions) as the RRF declines.&#xD;
&#xD;
      Methods/Design: IHDIP is a multicenter randomized experimental open trial. It is randomized&#xD;
      in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level&#xD;
      and non-commercial. It includes 152 patients older than 18 years with chronic renal disease&#xD;
      stage 5 and start HD as RRT, with a RRF of ≥ 4ml/min/1.73m2, measured by renal clearance of&#xD;
      urea (KrU). The intervention group includes 76 patients who will start with one session of HD&#xD;
      per week (incremental HD). The control group includes 76 patients who will start with three&#xD;
      sessions per week (conventional HD). The primary purpose is assessing the survival rate,&#xD;
      while the secondary purposes are the morbidity rate (hospital admissions), the clinical&#xD;
      parameters, the quality of life and the efficiency.&#xD;
&#xD;
      Discussion: This study will enable us to know with the highest level of scientific evidence,&#xD;
      the number of sessions a patient should receive when starting the HD treatment, depending on&#xD;
      his/her RRF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Conventional thrice-weekly HD for 3 to 5 hours in a health center in an outpatient basis is&#xD;
      the most used renal replacement therapy (RRT) regimen (1). However, it has an unacceptable&#xD;
      high mortality rate (10%-20% a year). In order to try to improve those results, new regimens&#xD;
      have been proposed. They are based on an increase of the HD dose and/or a higher number of&#xD;
      sessions (2). Nevertheless, inconsistent results in terms of clinical benefits with such&#xD;
      programs have been shown in recently published randomized and controlled trials (3,4),&#xD;
      together with a lower rate of vascular access success (5) and a lower maintenance of the RRF&#xD;
      (6) The National Kidney Foundation-Kidney Disease Outcomes Quality Initiate (NKD KDOQI&#xD;
      2015)(1) 2015 guidelines allow the reduction in the weekly HD dose for patients with a&#xD;
      residual kidney urea clearance (KrU) higher than 3ml/min/1.73m2. In these cases, the renal&#xD;
      clearance (Kr) is added to the dialysis clearance (Kd) obtained in 2 sessions per week, thus&#xD;
      obtaining the adequate dialysis dose (7,8) Surprisingly enough, few centers follow this&#xD;
      recommendation when over 50% of patients start HD with KrU &gt;3 mL/min (9).&#xD;
&#xD;
      Authors like Kalantar-Zadeh et al (9,10) in the U.S.A. or Teruel et al (11) in Spain have&#xD;
      published their experience with 2 HD sessions per week in incident patients. Through this&#xD;
      regime they have shown that the RRF is preserved and the survival rate is similar to the one&#xD;
      obtained with the conventional HD. This is due to the fact that the Kr has much greater&#xD;
      clinical weight than Kd7, since the RRF contributes to the production of vitamin D and&#xD;
      erythropoietine (12,13), and eliminates the protein-bound uremic toxins that are poorly&#xD;
      dialyzed (13,14). In other words, the RRF plays a fundamental role both in the dialysis&#xD;
      adequacy and in survival (15,16).&#xD;
&#xD;
      Currently, some authors are questioning the number of HD sessions with which a patient should&#xD;
      start the renal replacement therapy (RRT) (7, 17-19). Progressive HD is an initiation regimen&#xD;
      adapted to the patient's RRF. The frequency increases as the daily diuretic level declines&#xD;
      (7, 17-19).&#xD;
&#xD;
      The IHDIP trial20 aims at determining whether or not starting with one HD session per week&#xD;
      reduces mortality in incident patients and its influence in morbidity (hospital admissions),&#xD;
      clinical parameters, quality of life and efficiency with regard to the patients who start RRT&#xD;
      with the conventional method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 14, 2018</start_date>
  <completion_date type="Anticipated">September 6, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 6, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a prospective, multicenter, randomized clinical trial. It has two strata: for age (≥or&lt; 75 years old) and for KrU (≥or&lt; 5,5 ml/min/1.73m2). It is controlled through usual clinical practice.&#xD;
Intervention consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival rate</measure>
    <time_frame>24 months</time_frame>
    <description>Assess and compare survival in subjects with one session a week as an RRT starting regimen, compared to those patients who start RRT with the conventional method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital admissions</measure>
    <time_frame>24 months</time_frame>
    <description>Number of hospitalizations, for any cause; and number of days hospitalized for any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Kidney Function (RRF) maintenance .</measure>
    <time_frame>24 months</time_frame>
    <description>Reduction of glomerular filtration rate (GFR) and tubular function. Average urine volume and percentage of patients with anuria (≤200ml/day in two consecutive measurements).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of anemia</measure>
    <time_frame>3, 6, 9, 12, 18 and 24 months</time_frame>
    <description>Mean hemoglobin levels and Proportion of patients with Hb measurement inside the target range (10.5-12 g/dl) and The erythropoietin resistance index (ERI): ERI = weekly EPO (in UI)/patient's weight (in kg)/Hb (in gr/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone-mineral metabolism</measure>
    <time_frame>3, 6, 9, 12, 18 and 24 months</time_frame>
    <description>Mean levels of calcium, phosphorus and intac PTH levels. Estimate the percentage of patients within the therapeutic range; Calcium 8,4-9,5mg/dl, Phosphorus 3,5-5,5mg/dl and iPTH 150-300 pg/dl.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertrophic cardiomyopathy levels</measure>
    <time_frame>Basal, anual and end of the follow-un visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimation of the effect of treatment on quality of life</measure>
    <time_frame>3, 6, 9, 12, 18 and 24 months</time_frame>
    <description>Quality of life survey values from Kidney Disease and Quality of Life (KDQOL'36 Spanish) will be registered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing RRT efficiency (costs)</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>The number of sessions perform in subjects of incremental HDF group Vs number of sessions in the conventional HD group. The cost of each session is defined by the public contest for private haemodialysis clinics arranged by (that work to) the Health Service of Extremadura.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">152</enrollment>
  <condition>Renal Disease, End-Stage</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>76 patients who start RRT with the incremental HD regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>76 patients who start RRT with the conventional HD (3 sessions per week)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Incremental haemodialysis</intervention_name>
    <description>It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional haemodialysis</intervention_name>
    <description>It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group).</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged &gt;18 years, incident patients with stage 5 CKD who have chosen HD as RRT&#xD;
             initiation.&#xD;
&#xD;
          -  RRF measured by KrU ≥ 4 ml/min/1.73m2. In general, it is advised not to start HD with&#xD;
             a KrU&gt; 7.&#xD;
&#xD;
          -  Informed consent signed before starting any activity related to the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unplanned HD initiation (established in point 7.4 of the protocol)&#xD;
&#xD;
          -  Non incident patients, in other words, patients who were previously on RRT, either on&#xD;
             peritoneal dialysis, or on kidney transplant.&#xD;
&#xD;
          -  Active neoplasia at the moment of inclusion&#xD;
&#xD;
          -  Cardiovascular disease defined as: heart failure type IV of the New York Heart&#xD;
             Association (NYHA), unstable angina or ischemic cardiopathy which has caused any&#xD;
             admission in hospital in the last 3 months.&#xD;
&#xD;
          -  Cardiorenal syndrome&#xD;
&#xD;
          -  Active inflammatory disease with immunosuppressive treatment&#xD;
&#xD;
          -  Hepatorenal syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier L Deira Lorenzo, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Servicio Extremeño de Salud</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Miguel A Suarez Santisteban, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Servicio Extremeño de Salud</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FundeSalud. Junta de Extremadura</name>
      <address>
        <city>Mérida</city>
        <state>Badajoz</state>
        <zip>06800</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen del Puerto</name>
      <address>
        <city>Plasencia</city>
        <state>Cáceres</state>
        <zip>10600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro de Alcántara</name>
      <address>
        <city>Cáceres</city>
        <zip>10003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
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  <reference>
    <citation>Clark EG, Bagshaw SM. Unnecessary renal replacement therapy for acute kidney injury is harmful for renal recovery. Semin Dial. 2015 Jan-Feb;28(1):6-11. doi: 10.1111/sdi.12300. Epub 2014 Oct 30.</citation>
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  <reference>
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    <citation>Parra Moncasi E, Arenas Jimenez MD, Alonso M, Martinez MF, Gamen Pardo A, Rebollo P, Ortega Montoliu T, Martinez Terrer T, Alvarez-Ude F; Grupo de Gestion de la Calidad de la Sociedad Espanola de Nefrologia. Multicentre study of haemodialysis costs. Nefrologia. 2011;31(3):299-307. doi: 10.3265/Nefrologia.pre2011.Apr.10813. English, Spanish.</citation>
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  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>February 19, 2023</last_update_submitted>
  <last_update_submitted_qc>February 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>once-weekly haemodialysis</keyword>
  <keyword>incremental haemodialysis</keyword>
  <keyword>randomized clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03239808/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03239808/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03239808
org study id: IHDIP (P1712)
nct id: NCT03239808
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Incremental hemodialysis (HD) is a starting regime for renal replacement therapy
      (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal
      function (RRF). The frequency of sessions with which patients start HD -one or two sessions
      per week-, is lower than that for conventional HD three times per week. Such frequency is
      increased (from one to two sessions, and from two to three sessions) as the RRF declines.

      Methods/Design: IHDIP is a multicenter randomized experimental open trial. It is randomized
      in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level
      and non-commercial. It includes 152 patients older than 18 years with chronic renal disease
      stage 5 and start HD as RRT, with a RRF of ≥ 4ml/min/1.73m2, measured by renal clearance of
      urea (KrU). The intervention group includes 76 patients who will start with one session of HD
      per week (incremental HD). The control group includes 76 patients who will start with three
      sessions per week (conventional HD). The primary purpose is assessing the survival rate,
      while the secondary purposes are the morbidity rate (hospital admissions), the clinical
      parameters, the quality of life and the efficiency.

      Discussion: This study will enable us to know with the highest level of scientific evidence,
      the number of sessions a patient should receive when starting the HD treatment, depending on
      his/her RRF.
Conventional thrice-weekly HD for 3 to 5 hours in a health center in an outpatient basis is
      the most used renal replacement therapy (RRT) regimen (1). However, it has an unacceptable
      high mortality rate (10%-20% a year). In order to try to improve those results, new regimens
      have been proposed. They are based on an increase of the HD dose and/or a higher number of
      sessions (2). Nevertheless, inconsistent results in terms of clinical benefits with such
      programs have been shown in recently published randomized and controlled trials (3,4),
      together with a lower rate of vascular access success (5) and a lower maintenance of the RRF
      (6) The National Kidney Foundation-Kidney Disease Outcomes Quality Initiate (NKD KDOQI
      2015)(1) 2015 guidelines allow the reduction in the weekly HD dose for patients with a
      residual kidney urea clearance (KrU) higher than 3ml/min/1.73m2. In these cases, the renal
      clearance (Kr) is added to the dialysis clearance (Kd) obtained in 2 sessions per week, thus
      obtaining the adequate dialysis dose (7,8) Surprisingly enough, few centers follow this
      recommendation when over 50% of patients start HD with KrU >3 mL/min (9).

      Authors like Kalantar-Zadeh et al (9,10) in the U.S.A. or Teruel et al (11) in Spain have
      published their experience with 2 HD sessions per week in incident patients. Through this
      regime they have shown that the RRF is preserved and the survival rate is similar to the one
      obtained with the conventional HD. This is due to the fact that the Kr has much greater
      clinical weight than Kd7, since the RRF contributes to the production of vitamin D and
      erythropoietine (12,13), and eliminates the protein-bound uremic toxins that are poorly
      dialyzed (13,14). In other words, the RRF plays a fundamental role both in the dialysis
      adequacy and in survival (15,16).

      Currently, some authors are questioning the number of HD sessions with which a patient should
      start the renal replacement therapy (RRT) (7, 17-19). Progressive HD is an initiation regimen
      adapted to the patient's RRF. The frequency increases as the daily diuretic level declines
      (7, 17-19).

      The IHDIP trial20 aims at determining whether or not starting with one HD session per week
      reduces mortality in incident patients and its influence in morbidity (hospital admissions),
      clinical parameters, quality of life and efficiency with regard to the patients who start RRT
      with the conventional method.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a prospective, multicenter, randomized clinical trial. It has two strata: for age (≥or< 75 years old) and for KrU (≥or< 5,5 ml/min/1.73m2). It is controlled through usual clinical practice.
Intervention consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression.
primary purpose: Treatment
masking: None (Open Label)
measure: Survival rate
time frame: 24 months
description: Assess and compare survival in subjects with one session a week as an RRT starting regimen, compared to those patients who start RRT with the conventional method
measure: Hospital admissions
time frame: 24 months
description: Number of hospitalizations, for any cause; and number of days hospitalized for any cause
measure: Residual Kidney Function (RRF) maintenance .
time frame: 24 months
description: Reduction of glomerular filtration rate (GFR) and tubular function. Average urine volume and percentage of patients with anuria (≤200ml/day in two consecutive measurements).
measure: Analysis of anemia
time frame: 3, 6, 9, 12, 18 and 24 months
description: Mean hemoglobin levels and Proportion of patients with Hb measurement inside the target range (10.5-12 g/dl) and The erythropoietin resistance index (ERI): ERI = weekly EPO (in UI)/patient's weight (in kg)/Hb (in gr/dl)
measure: Bone-mineral metabolism
time frame: 3, 6, 9, 12, 18 and 24 months
description: Mean levels of calcium, phosphorus and intac PTH levels. Estimate the percentage of patients within the therapeutic range; Calcium 8,4-9,5mg/dl, Phosphorus 3,5-5,5mg/dl and iPTH 150-300 pg/dl.
measure: Hypertrophic cardiomyopathy levels
time frame: Basal, anual and end of the follow-un visit
measure: Estimation of the effect of treatment on quality of life
time frame: 3, 6, 9, 12, 18 and 24 months
description: Quality of life survey values from Kidney Disease and Quality of Life (KDQOL'36 Spanish) will be registered.
measure: Assessing RRT efficiency (costs)
time frame: 12 and 24 months
description: The number of sessions perform in subjects of incremental HDF group Vs number of sessions in the conventional HD group. The cost of each session is defined by the public contest for private haemodialysis clinics arranged by (that work to) the Health Service of Extremadura.
arm group label: Experimental group
arm group type: Experimental
description: 76 patients who start RRT with the incremental HD regimen.
arm group label: Control group
arm group type: Active Comparator
description: 76 patients who start RRT with the conventional HD (3 sessions per week)
intervention type: Procedure
intervention name: Incremental haemodialysis
description: It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression
arm group label: Experimental group
intervention type: Procedure
intervention name: Conventional haemodialysis
description: It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group).
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javier L Deira Lorenzo, PhD MD
role: Principal Investigator
affiliation: Servicio Extremeño de Salud
last name: Miguel A Suarez Santisteban, MD
role: Principal Investigator
affiliation: Servicio Extremeño de Salud
facility: 
facility: 
facility: 
country: Spain
citation: National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015. Erratum In: Am J Kidney Dis. 2016 Mar;67(3):534.
PMID: 26498416
citation: Chan CT, Covic A, Craig JC, Davenport A, Kasiske BL, Kuhlmann MK, Levin NW, Li PK, Locatelli F, Rocco MV, Wheeler DC. Novel techniques and innovation in blood purification: a clinical update from Kidney Disease: Improving Global Outcomes. Kidney Int. 2013 Mar;83(3):359-71. doi: 10.1038/ki.2012.450. Epub 2013 Jan 16.
PMID: 23325091
citation: Chertow GM, Levin NW, Beck GJ, Daugirdas JT, Eggers PW, Kliger AS, Larive B, Rocco MV, Greene T; Frequent Hemodialysis Network (FHN) Trials Group. Long-Term Effects of Frequent In-Center Hemodialysis. J Am Soc Nephrol. 2016 Jun;27(6):1830-6. doi: 10.1681/ASN.2015040426. Epub 2015 Oct 14.
PMID: 26467779
citation: Rocco MV, Daugirdas JT, Greene T, Lockridge RS, Chan C, Pierratos A, Lindsay R, Larive B, Chertow GM, Beck GJ, Eggers PW, Kliger AS; FHN Trial Group. Long-term Effects of Frequent Nocturnal Hemodialysis on Mortality: The Frequent Hemodialysis Network (FHN) Nocturnal Trial. Am J Kidney Dis. 2015 Sep;66(3):459-68. doi: 10.1053/j.ajkd.2015.02.331. Epub 2015 Apr 8.
PMID: 25863828
citation: Suri RS, Larive B, Sherer S, Eggers P, Gassman J, James SH, Lindsay RM, Lockridge RS, Ornt DB, Rocco MV, Ting GO, Kliger AS; Frequent Hemodialysis Network Trial Group. Risk of vascular access complications with frequent hemodialysis. J Am Soc Nephrol. 2013 Feb;24(3):498-505. doi: 10.1681/ASN.2012060595. Epub 2013 Feb 7.
PMID: 23393319
citation: Daugirdas JT, Greene T, Rocco MV, Kaysen GA, Depner TA, Levin NW, Chertow GM, Ornt DB, Raimann JG, Larive B, Kliger AS; FHN Trial Group. Effect of frequent hemodialysis on residual kidney function. Kidney Int. 2013 May;83(5):949-58. doi: 10.1038/ki.2012.457. Epub 2013 Jan 23.
PMID: 23344474
citation: Clark EG, Bagshaw SM. Unnecessary renal replacement therapy for acute kidney injury is harmful for renal recovery. Semin Dial. 2015 Jan-Feb;28(1):6-11. doi: 10.1111/sdi.12300. Epub 2014 Oct 30.
PMID: 25359104
citation: Mathew AT, Fishbane S, Obi Y, Kalantar-Zadeh K. Preservation of residual kidney function in hemodialysis patients: reviving an old concept. Kidney Int. 2016 Aug;90(2):262-271. doi: 10.1016/j.kint.2016.02.037. Epub 2016 May 12.
PMID: 27182000
citation: Patel N, Hu SL. Preserving residual renal function in dialysis: what we know. Semin Dial. 2015 May-Jun;28(3):250-8. doi: 10.1111/sdi.12302. Epub 2014 Sep 18.
PMID: 25231758
citation: Casino FG, Basile C. The variable target model: a paradigm shift in the incremental haemodialysis prescription. Nephrol Dial Transplant. 2017 Jan 1;32(1):182-190. doi: 10.1093/ndt/gfw339.
PMID: 27742823
citation: Shafi T, Jaar BG, Plantinga LC, Fink NE, Sadler JH, Parekh RS, Powe NR, Coresh J. Association of residual urine output with mortality, quality of life, and inflammation in incident hemodialysis patients: the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. Am J Kidney Dis. 2010 Aug;56(2):348-58. doi: 10.1053/j.ajkd.2010.03.020. Epub 2010 Jun 3.
PMID: 20605303
citation: van der Wal WM, Noordzij M, Dekker FW, Boeschoten EW, Krediet RT, Korevaar JC, Geskus RB; Netherlands Cooperative Study on the Adequacy of Dialysis Study Group (NECOSAD). Full loss of residual renal function causes higher mortality in dialysis patients; findings from a marginal structural model. Nephrol Dial Transplant. 2011 Sep;26(9):2978-83. doi: 10.1093/ndt/gfq856. Epub 2011 Feb 11.
PMID: 21317411
citation: Obi Y, Streja E, Rhee CM, Ravel V, Amin AN, Cupisti A, Chen J, Mathew AT, Kovesdy CP, Mehrotra R, Kalantar-Zadeh K. Incremental Hemodialysis, Residual Kidney Function, and Mortality Risk in Incident Dialysis Patients: A Cohort Study. Am J Kidney Dis. 2016 Aug;68(2):256-265. doi: 10.1053/j.ajkd.2016.01.008. Epub 2016 Feb 9.
PMID: 26867814
citation: Wong J, Vilar E, Davenport A, Farrington K. Incremental haemodialysis. Nephrol Dial Transplant. 2015 Oct;30(10):1639-48. doi: 10.1093/ndt/gfv231. Epub 2015 Jun 1.
PMID: 26038351
citation: Termorshuizen F, Dekker FW, van Manen JG, Korevaar JC, Boeschoten EW, Krediet RT; NECOSAD Study Group. Relative contribution of residual renal function and different measures of adequacy to survival in hemodialysis patients: an analysis of the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD)-2. J Am Soc Nephrol. 2004 Apr;15(4):1061-70. doi: 10.1097/01.asn.0000117976.29592.93.
PMID: 15034110
citation: Vilar E, Wellsted D, Chandna SM, Greenwood RN, Farrington K. Residual renal function improves outcome in incremental haemodialysis despite reduced dialysis dose. Nephrol Dial Transplant. 2009 Aug;24(8):2502-10. doi: 10.1093/ndt/gfp071. Epub 2009 Feb 24.
PMID: 19240122
citation: Zhang M, Wang M, Li H, Yu P, Yuan L, Hao C, Chen J, Kalantar-Zadeh K. Association of initial twice-weekly hemodialysis treatment with preservation of residual kidney function in ESRD patients. Am J Nephrol. 2014;40(2):140-50. doi: 10.1159/000365819. Epub 2014 Aug 23.
PMID: 25171342
citation: Fernandez Lucas M, Teruel JL. Incremental hemodialysis schedule at the start of renal replacement therapy. Nefrologia. 2017 Jan-Feb;37(1):1-4. doi: 10.1016/j.nefro.2016.08.002. Epub 2016 Oct 1. No abstract available. English, Spanish.
PMID: 27707578
citation: Toth-Manikowski SM, Shafi T. Hemodialysis Prescription for Incident Patients: Twice Seems Nice, But Is It Incremental? Am J Kidney Dis. 2016 Aug;68(2):180-183. doi: 10.1053/j.ajkd.2016.04.005. No abstract available.
PMID: 27477358
citation: Caria S, Cupisti A, Sau G, Bolasco P. The incremental treatment of ESRD: a low-protein diet combined with weekly hemodialysis may be beneficial for selected patients. BMC Nephrol. 2014 Oct 29;15:172. doi: 10.1186/1471-2369-15-172.
PMID: 25352299
citation: Bolasco P, Cupisti A, Locatelli F, Caria S, Kalantar-Zadeh K. Dietary Management of Incremental Transition to Dialysis Therapy: Once-Weekly Hemodialysis Combined With Low-Protein Diet. J Ren Nutr. 2016 Nov;26(6):352-359. doi: 10.1053/j.jrn.2016.01.015. Epub 2016 Feb 28. Erratum In: J Ren Nutr. 2017 Jan;27(1):74.
PMID: 26936151
citation: Libetta C, Esposito P, Dal Canton A. Once-weekly hemodialysis: a single-center experience. Am J Kidney Dis. 2015 Feb;65(2):343. doi: 10.1053/j.ajkd.2014.07.034. No abstract available.
PMID: 25616635
citation: Parra Moncasi E, Arenas Jimenez MD, Alonso M, Martinez MF, Gamen Pardo A, Rebollo P, Ortega Montoliu T, Martinez Terrer T, Alvarez-Ude F; Grupo de Gestion de la Calidad de la Sociedad Espanola de Nefrologia. Multicentre study of haemodialysis costs. Nefrologia. 2011;31(3):299-307. doi: 10.3265/Nefrologia.pre2011.Apr.10813. English, Spanish.
PMID: 21629336
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
provided document: 
provided document: 