<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/NCT02987465</url>
  </required_header>
  <id_info>
    <org_study_id>OPERA-CKD (AO94224)</org_study_id>
    <nct_id>NCT02987465</nct_id>
  </id_info>
  <brief_title>Evaluating the Effect of Standard-of-care Erythropoiesis-stimulating Agents on Forearm Blood Flow in Nondialysis-dependent Subjects With Anaemia Associated With Chronic Kidney Disease.</brief_title>
  <acronym>OPERA-CKD</acronym>
  <official_title>An Observational, Open-label Pilot Study to Evaluate the Effect of Standard-of-care Erythropoiesis-stimulating Agents (Darbepoetin Alfa) on Forearm Blood Flow in Nondialysis-dependent Subjects With Anaemia Associated With Chronic Kidney Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cambridge University Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In people diagnosed with chronic kidney disease (CKD) anaemia is a common problem and is&#xD;
      often treated with EPO (Erythropoietin). One form of EPO used is Darbepoetin (Aranesp®). EPO&#xD;
      is safe to use but it has been associated with a rise in blood pressure (BP) in some&#xD;
      individuals. The reasons for this are not clear. To try to explain this, this study will look&#xD;
      at how EPO affects certain substances in the blood that influence how blood vessels contract&#xD;
      and relax. This will be conducted by infusing small amounts of Acetylcholine, BQ123 and&#xD;
      Noradrenaline into the arm vessels of volunteers using an established method called Forearm&#xD;
      blood flow (plethysmography). Volunteers recruited for this study will include CKD patients&#xD;
      undergoing therapy with Darbepoetin as part of their normal NHS care as well as healthy&#xD;
      people not on treatment, who will act as controls. This is an observational pilot study of&#xD;
      changes in physiology before and after Darbepoetin. It will provide valuable data for a later&#xD;
      study comparing Darbepoetin to novel agents which work via different pathways to treat&#xD;
      anaemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot proposal to understand the changes in physiology in patients undergoing&#xD;
      scheduled therapy with Darbepoetin as part of their normal NHS care. It is therefore an&#xD;
      observational pilot study of changes in physiology before and after Darbepoetin. Conventional&#xD;
      erythropoiesis stimulating agents (ESAs) are widely used to improve haemoglobin production&#xD;
      and reduce anaemia in subjects with chronic kidney disease (CKD). However, ESAs are&#xD;
      associated with the development of hypertension and increased cardiovascular morbidity and&#xD;
      mortality. A number of potential underlying pathophysiological mechanisms have been&#xD;
      postulated, mostly concerning around altered sensitivity to, or circulating levels of,&#xD;
      endogenous vasoactive mediators. However, the existing data are inconsistent. Hand et al.&#xD;
      found that short-term therapy with recombinant erythropoietin was associated with a rise in&#xD;
      blood pressure, and an increase in vasoconstrictor responsiveness to infused noradrenaline,&#xD;
      but not to endothelin-1. Serum endothelin-1 levels were elevated compared to controls at&#xD;
      baseline, but did not change after erythropoietin therapy. Other groups have reported that&#xD;
      ESA administration increases plasma levels of endothelin-1, and that this is strongly&#xD;
      correlated with the increase in mean arterial pressure (MAP). Human endothelial cells&#xD;
      incubated in ESAs show decreased eNOS expression and endothelial nitric oxide (NO)&#xD;
      production. Ex-vivo studies in resistance vessels of subjects with CKD found impaired&#xD;
      endothelial function, as assessed by acetylcholine mediated vasodilatation, which was&#xD;
      partially reversed by blockade of the endothelin receptor (ET-A). In vivo acute and chronic&#xD;
      ESA administration also impairs endothelial function, which is often considered as a&#xD;
      surrogate of nitric oxide bioavailability.&#xD;
&#xD;
      Recently, newer agents have been postulated as a novel alternative to ESAs for treating renal&#xD;
      anaemia. However, cardiovascular effects are incompletely characterised. Studies elucidating&#xD;
      the mechanisms for ESA induced vasoconstriction and possible effects that promote&#xD;
      cardiovascular disease are necessary and it would be imperative to study whether the use of&#xD;
      these novel agents avoids these effects, potentially making them a better alternative to&#xD;
      ESAs.&#xD;
&#xD;
      This pilot study aims to determine the putative mechanisms which may be involved in the BP&#xD;
      response to ESA use in patients with anaemia associated with CKD who are EPO naïve within the&#xD;
      last 12 months. Information gained from this study will inform a larger clinical trial that&#xD;
      is being planned. Healthy volunteers will be recruited to provide a baseline of normal&#xD;
      responses to compare against.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Actual">May 21, 2018</completion_date>
  <primary_completion_date type="Actual">May 21, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Response to intra-arterial acetylcholine</measure>
    <time_frame>CKD patients: Measured at baseline and at the end of the 6 week treatment period</time_frame>
    <description>Change in forearm blood flow responses as measured by venous occlusion plethysmography, in response to intra-arterial acetylcholine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response to intra-arterial Noradrenaline</measure>
    <time_frame>CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin</time_frame>
    <description>Change in forearm blood flow responses, as measured by venous occlusion plethysmography, in response to intra-arterial Noradrenaline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to intra-arterial BQ123</measure>
    <time_frame>CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin</time_frame>
    <description>Change in forearm blood flow responses as measured by venous occlusion plethysmography, in response to intra-arterial BQ123</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean arterial blood pressure</measure>
    <time_frame>CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin</time_frame>
    <description>Change in mean arterial blood pressure, systolic blood pressure and diastolic blood pressure post-Darbepoetin-Alfa over 6 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Arterial stiffness</measure>
    <time_frame>CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin</time_frame>
    <description>Changes in arterial stiffness post-darbepoetin-alfa</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlations between individual challenge agent</measure>
    <time_frame>CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin</time_frame>
    <description>Correlations between individual challenge agent forearm blood flow responses and change in blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forearm blood flow responses to Acetylcholine, Noradrenaline and BQ123 in patients with CKD compared to healthy volunteers</measure>
    <time_frame>Healthy Volunteers: Measured at baseline; CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin</time_frame>
    <description>Change in forearm blood flow responses to Acetylcholine, Noradrenaline and BQ123 in patients with anaemia associated with CKD at baseline compared to healthy volunteers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responses to Acetylcholine, Noradrenaline and BQ123 in patients with CKD post-Darbepoetin compared to healthy volunteers</measure>
    <time_frame>Healthy Volunteers: Measured at baseline; CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin</time_frame>
    <description>Change in forearm blood flow responses to Acetylcholine, Noradrenaline and BQ123 in patients with anaemia associated with CKD post-Darbepoetin compared to healthy volunteers</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Chronic Kidney Disease patients</arm_group_label>
    <description>Up to 12 patients with anaemia associated with CKD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Up to 12 healthy subjects will be recruited such that age and gender are similar to the CKD patients. These subjects will be recruited as negative controls for a baseline assessment of healthy physiology. These subjects will not be treated with Darbepoetin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Darbepoetin Alfa</intervention_name>
    <description>Darbepoetin is not a study drug and is prescribed as part of routine treatment of anaemia in CKD1. Darbepoetin is licensed for use for the treatment of anaemia in the context of CKD. It will be provided as part of the standard clinical care of the renal patients in this study. Healthy Volunteers will not be treated with Darbepoetin.</description>
    <arm_group_label>Chronic Kidney Disease patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetylcholine</intervention_name>
    <description>Acetylcholine is being used as a challenge agent in this study and assesses NO-mediated vasodilation</description>
    <arm_group_label>Chronic Kidney Disease patients</arm_group_label>
    <arm_group_label>Healthy Volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Noradrenaline</intervention_name>
    <description>Noradrenaline is being used as a challenge agent in this study and is an endogenous a1 adrenoceptor agonist</description>
    <arm_group_label>Chronic Kidney Disease patients</arm_group_label>
    <arm_group_label>Healthy Volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BQ 123</intervention_name>
    <description>BQ 123 is being used as a challenge agent in this study and is an (Endothelin A) ETA receptor agonist.</description>
    <arm_group_label>Chronic Kidney Disease patients</arm_group_label>
    <arm_group_label>Healthy Volunteers</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Some serum samples will be collected and stored for future analysis as part of the OPERA-CKD&#xD;
      study.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 12 patients with anaemia associated with chronic kidney disease (CKD).&#xD;
&#xD;
        Up to 12 healthy volunteers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria CKD patients:&#xD;
&#xD;
          -  Provided written informed consent to participate&#xD;
&#xD;
          -  Be aged 18 years or over&#xD;
&#xD;
          -  Clinically suitable for EPO (Darbepoetin) therapy as part of routine NHS standard of&#xD;
             care for anaemia due to chronic kidney disease (CKD)&#xD;
&#xD;
          -  No prior EPO treatment within the preceding 12 months&#xD;
&#xD;
          -  Palpable brachial artery&#xD;
&#xD;
        Inclusion Criteria Healthy Volunteers:&#xD;
&#xD;
          -  Provided written informed consent to participate&#xD;
&#xD;
          -  Aged 18 years or over&#xD;
&#xD;
          -  Blood pressure &lt;140/90&#xD;
&#xD;
          -  Normal haematology and renal function (defined as a normal creatinine and eGFR&#xD;
             measured at any time in the last 6 months or at screening)&#xD;
&#xD;
          -  Not on any regular prescribed medication&#xD;
&#xD;
          -  Palpable brachial artery&#xD;
&#xD;
        Exclusion criteria CKD patients:&#xD;
&#xD;
          -  Kidney transplant: Planned living-related kidney transplant within 26 weeks&#xD;
&#xD;
          -  Patients on PDE5 inhibitors, alpha blockers, or nitrates (other than PRN GTN), unless&#xD;
             they can be omitted until after the forearm study on the day of the visit&#xD;
&#xD;
          -  MI or acute coronary syndrome in the preceding ≤ 4 weeks prior to screening&#xD;
&#xD;
          -  Stroke or transient ischemic attack in the preceding ≤ 4 weeks prior to screening&#xD;
&#xD;
          -  Known clinical diagnosis of Heart failure: NYHA Class III-IV heart failure, as defined&#xD;
             by the New York Heart Association (NYHA) functional classification system.&#xD;
&#xD;
          -  Clinic Blood pressure: sustained BP &gt; 170/100 mm Hg (on repeated measurements)&#xD;
&#xD;
          -  Pregnancy - Non-sterilised, pre-menopausal women will undergo urinary beta-HCG testing&#xD;
             at every visit and be given advice on contraceptive use in the PIS.&#xD;
&#xD;
          -  Any other reason for exclusion from this study in the opinion of the Principal&#xD;
             Investigator&#xD;
&#xD;
        Exclusion Criteria Healthy Volunteers:&#xD;
&#xD;
          -  Any condition which, in the opinion of the investigator, precludes enrolment&#xD;
&#xD;
          -  Undergoing investigation for any serious medical condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Cheriyan, MBCHB, MA, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cambridge University Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Addenbrooke's Hospital</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cambridge University Hospitals NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Joseph Cheriyan, MD</investigator_full_name>
    <investigator_title>Consultant Physician &amp; Clinical Pharmacologist/Assoc Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Norepinephrine</mesh_term>
    <mesh_term>Acetylcholine</mesh_term>
    <mesh_term>Darbepoetin alfa</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02987465
org study id: OPERA-CKD (AO94224)
nct id: NCT02987465
lead sponsor: 
collaborator: 
has dmc: No
In people diagnosed with chronic kidney disease (CKD) anaemia is a common problem and is
      often treated with EPO (Erythropoietin). One form of EPO used is Darbepoetin (Aranesp®). EPO
      is safe to use but it has been associated with a rise in blood pressure (BP) in some
      individuals. The reasons for this are not clear. To try to explain this, this study will look
      at how EPO affects certain substances in the blood that influence how blood vessels contract
      and relax. This will be conducted by infusing small amounts of Acetylcholine, BQ123 and
      Noradrenaline into the arm vessels of volunteers using an established method called Forearm
      blood flow (plethysmography). Volunteers recruited for this study will include CKD patients
      undergoing therapy with Darbepoetin as part of their normal NHS care as well as healthy
      people not on treatment, who will act as controls. This is an observational pilot study of
      changes in physiology before and after Darbepoetin. It will provide valuable data for a later
      study comparing Darbepoetin to novel agents which work via different pathways to treat
      anaemia.
This is a pilot proposal to understand the changes in physiology in patients undergoing
      scheduled therapy with Darbepoetin as part of their normal NHS care. It is therefore an
      observational pilot study of changes in physiology before and after Darbepoetin. Conventional
      erythropoiesis stimulating agents (ESAs) are widely used to improve haemoglobin production
      and reduce anaemia in subjects with chronic kidney disease (CKD). However, ESAs are
      associated with the development of hypertension and increased cardiovascular morbidity and
      mortality. A number of potential underlying pathophysiological mechanisms have been
      postulated, mostly concerning around altered sensitivity to, or circulating levels of,
      endogenous vasoactive mediators. However, the existing data are inconsistent. Hand et al.
      found that short-term therapy with recombinant erythropoietin was associated with a rise in
      blood pressure, and an increase in vasoconstrictor responsiveness to infused noradrenaline,
      but not to endothelin-1. Serum endothelin-1 levels were elevated compared to controls at
      baseline, but did not change after erythropoietin therapy. Other groups have reported that
      ESA administration increases plasma levels of endothelin-1, and that this is strongly
      correlated with the increase in mean arterial pressure (MAP). Human endothelial cells
      incubated in ESAs show decreased eNOS expression and endothelial nitric oxide (NO)
      production. Ex-vivo studies in resistance vessels of subjects with CKD found impaired
      endothelial function, as assessed by acetylcholine mediated vasodilatation, which was
      partially reversed by blockade of the endothelin receptor (ET-A). In vivo acute and chronic
      ESA administration also impairs endothelial function, which is often considered as a
      surrogate of nitric oxide bioavailability.

      Recently, newer agents have been postulated as a novel alternative to ESAs for treating renal
      anaemia. However, cardiovascular effects are incompletely characterised. Studies elucidating
      the mechanisms for ESA induced vasoconstriction and possible effects that promote
      cardiovascular disease are necessary and it would be imperative to study whether the use of
      these novel agents avoids these effects, potentially making them a better alternative to
      ESAs.

      This pilot study aims to determine the putative mechanisms which may be involved in the BP
      response to ESA use in patients with anaemia associated with CKD who are EPO naïve within the
      last 12 months. Information gained from this study will inform a larger clinical trial that
      is being planned. Healthy volunteers will be recruited to provide a baseline of normal
      responses to compare against.
observational model: Case-Control
time perspective: Prospective
measure: Response to intra-arterial acetylcholine
time frame: CKD patients: Measured at baseline and at the end of the 6 week treatment period
description: Change in forearm blood flow responses as measured by venous occlusion plethysmography, in response to intra-arterial acetylcholine
measure: Response to intra-arterial Noradrenaline
time frame: CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin
description: Change in forearm blood flow responses, as measured by venous occlusion plethysmography, in response to intra-arterial Noradrenaline
measure: Response to intra-arterial BQ123
time frame: CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin
description: Change in forearm blood flow responses as measured by venous occlusion plethysmography, in response to intra-arterial BQ123
measure: Change in mean arterial blood pressure
time frame: CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin
description: Change in mean arterial blood pressure, systolic blood pressure and diastolic blood pressure post-Darbepoetin-Alfa over 6 weeks of treatment
measure: Changes in Arterial stiffness
time frame: CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin
description: Changes in arterial stiffness post-darbepoetin-alfa
measure: Correlations between individual challenge agent
time frame: CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin
description: Correlations between individual challenge agent forearm blood flow responses and change in blood pressure
measure: Forearm blood flow responses to Acetylcholine, Noradrenaline and BQ123 in patients with CKD compared to healthy volunteers
time frame: Healthy Volunteers: Measured at baseline; CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin
description: Change in forearm blood flow responses to Acetylcholine, Noradrenaline and BQ123 in patients with anaemia associated with CKD at baseline compared to healthy volunteers
measure: Responses to Acetylcholine, Noradrenaline and BQ123 in patients with CKD post-Darbepoetin compared to healthy volunteers
time frame: Healthy Volunteers: Measured at baseline; CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin
description: Change in forearm blood flow responses to Acetylcholine, Noradrenaline and BQ123 in patients with anaemia associated with CKD post-Darbepoetin compared to healthy volunteers
arm group label: Chronic Kidney Disease patients
description: Up to 12 patients with anaemia associated with CKD.
arm group label: Healthy Volunteers
description: Up to 12 healthy subjects will be recruited such that age and gender are similar to the CKD patients. These subjects will be recruited as negative controls for a baseline assessment of healthy physiology. These subjects will not be treated with Darbepoetin.
intervention type: Drug
intervention name: Darbepoetin Alfa
description: Darbepoetin is not a study drug and is prescribed as part of routine treatment of anaemia in CKD1. Darbepoetin is licensed for use for the treatment of anaemia in the context of CKD. It will be provided as part of the standard clinical care of the renal patients in this study. Healthy Volunteers will not be treated with Darbepoetin.
arm group label: Chronic Kidney Disease patients
intervention type: Drug
intervention name: Acetylcholine
description: Acetylcholine is being used as a challenge agent in this study and assesses NO-mediated vasodilation
arm group label: Chronic Kidney Disease patients
arm group label: Healthy Volunteers
intervention type: Drug
intervention name: Noradrenaline
description: Noradrenaline is being used as a challenge agent in this study and is an endogenous a1 adrenoceptor agonist
arm group label: Chronic Kidney Disease patients
arm group label: Healthy Volunteers
intervention type: Drug
intervention name: BQ 123
description: BQ 123 is being used as a challenge agent in this study and is an (Endothelin A) ETA receptor agonist.
arm group label: Chronic Kidney Disease patients
arm group label: Healthy Volunteers
Some serum samples will be collected and stored for future analysis as part of the OPERA-CKD
      study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph Cheriyan, MBCHB, MA, FRCP
role: Principal Investigator
affiliation: Cambridge University Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Cambridge University Hospitals NHS Foundation Trust
investigator full name: Joseph Cheriyan, MD
investigator title: Consultant Physician & Clinical Pharmacologist/Assoc Lecturer
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Cardiovascular Diseases
mesh term: Norepinephrine
mesh term: Acetylcholine
mesh term: Darbepoetin alfa
sharing ipd: Undecided