<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/NCT04424602</url>
  </required_header>
  <id_info>
    <org_study_id>0000085</org_study_id>
    <nct_id>NCT04424602</nct_id>
  </id_info>
  <brief_title>Comparison between2 Drugs in Lupus Nephritis</brief_title>
  <official_title>Comparison Between Mycophenolate andCyclophosphamide in the Treatment of Lupus Nephritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Azhar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this work is to study the effect and side effects of the cyclophosphamide versus&#xD;
      mycophenolate in lupus nephritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Systemic lupus erythematosus (SLE), also known simply as lupus, is an autoimmune disease in&#xD;
      which the body's immune system mistakenly attacks healthy tissue in many parts of the body.&#xD;
&#xD;
      Symptoms vary between people and may be mild to severe. common symptoms include painful and&#xD;
      swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling&#xD;
      tired, and a red rash which is most commonly on the face. Often there are periods of illness,&#xD;
      called flares, and periods of remission during which there are few symptoms.painless passage&#xD;
      of blood or protein in the urine may often be the only presenting sign of kidney involvement.&#xD;
&#xD;
      Acute or chronic renal impairment may develop with lupus nephritis, leading to acute or&#xD;
      end-stage kidney failure. Because of early recognition and management of SLE, end-stage renal&#xD;
      failure occurs in less than 5% of cases; except in the black population, where the risk is&#xD;
      many times.Nephritis is the most severe manifestation of lupus. Between 1950s and 1970s,&#xD;
      corticosteroids were used for the treatment of lupus nephritis (LN) ,and using of&#xD;
      cyclophosphamide(CPM), improved the outcome dramatically with 5 years survival increasing&#xD;
      from 17% to 80%.Subsequently, intravenous (iv) CPM became the standard of care in induction&#xD;
      regimes; however, ivCPM was associated with complications such as bladder toxicity, gonadal&#xD;
      problems, and infections. To reduce the toxicity, low-dose of 500mg iv(CPM) every two weeks&#xD;
      for six months showed equivalent efficacy and less side effect.&#xD;
&#xD;
      Mycophenolatemofetil(MMF) is widely used in solid organ transplantation and it reduces the&#xD;
      rate of acute rejection following renal transplantation.&#xD;
&#xD;
      It has also been used to treat patients with other immune-mediated disorders such as&#xD;
      immunoglobulin A nephropathy, small-vessel vasculitides and psoriasis .&#xD;
&#xD;
      Lupus nephritisis inflammation of the kidney that is caused by systemic lupus erythematous&#xD;
      (SLE). Lupus nephritis happens when lupus involves the kidneys.its symptoms, though, are not&#xD;
      always dramatic. for many, the first noticeable symptom is swelling of the legs, ankles and&#xD;
      feet. less often, there can be swelling in the face or hands.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2021</start_date>
  <completion_date type="Actual">September 9, 2021</completion_date>
  <primary_completion_date type="Actual">September 5, 2021</primary_completion_date>
  <phase>Phase 4</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 study will be carried on40 patients with systemic lupus erythematous with lupus nephritis.the age group of patients will be between 20 to50 years.All lupus nephritis patients will be divided randomly into two groups. First group will be 20female patients on lupus nephritis .They will be given oral corticosteroid( 1mg/kg per day) and intra venous cyclophosphamide 500mg once every two weeks for 6months. Second group will be 20female patients on lupus nephritis they will be given oral corticosteroid(1mg/kg per day) and oral mycophenolat 2 to 3mg/kg for 6 months</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>serume creatinine (sCR)</measure>
    <time_frame>6 months</time_frame>
    <description>to measure treatment response and determine renal function These investigation will be done before starting the pharmacotherapy and after the end of the therapy.its normal range from(0.4 to1.5 mg/dl)its level increase in lupus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood uerea nitrogen.</measure>
    <time_frame>6 months</time_frame>
    <description>to measure treatment response and determine renal function These investigation will be done before starting the pharmacotherapy and after the end of the therapy.its normal range ,around7to20mg/dl(2.5to7.1mmol) its level increase in lupus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Erythrocyte sedimentation rate.(ESR)</measure>
    <time_frame>6 months.</time_frame>
    <description>can help us to determine if patients have inflammation.These investigation will be done before starting the pharmacotherapy and after the end of the therapy .its range from (15to10mm/hr)its level increase in lupus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Anti ds DNA</measure>
    <time_frame>6 months</time_frame>
    <description>will done for diagnosis and ascertain activity of lupusThese investigation will be done before starting the pharmacotherapy and after the end of the therapy if the antidsDNA level are high the lupus may be active and if its level is low the lupus is less active.its rangr(&lt;18iu/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Complement 3 (C3)</measure>
    <time_frame>6 months</time_frame>
    <description>will done for diagnosis and ascertain activity of lupus These investigation will be done before starting the pharmacotherapy and after the end of the therapy .c3range from75to175mg/lcomplementc3 level are lower in lupus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• complete blood count.(CBC)( red blood cells,white blood cells,platelets)</measure>
    <time_frame>6 months</time_frame>
    <description>to know all information about red blood cells,white blood cells,platelets and effect of two drus on it.These investigation will be done before starting the pharmacotherapy and after the end of the therapy at six months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• 24h urine test for creatinine clearance and protien excretion.</measure>
    <time_frame>6 months.</time_frame>
    <description>the test is used to check kideny function.•These investigation will be done before starting the pharmacotherapy and after the end of the therapy.normal urinary protie-to-creatinine ratio is&lt;0.2.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Lupus Nephritis</condition>
  <arm_group>
    <arm_group_label>cyclophosphamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants will receive intra venous cyclophosphamide 500mg once every two weeks for 6months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mycophenolate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>participants will receive oral mycophenolat 2 to 3mg/kg for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cyclo phosphamide</intervention_name>
    <description>500mg vial</description>
    <arm_group_label>cyclophosphamide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mycophenolate</intervention_name>
    <description>500mg film-coated tablets.</description>
    <arm_group_label>mycophenolate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients have systemic lupus erythromatosis with lupus nephritis either newly&#xD;
             diagnosed or with history of SLE with lupus nephrits&#xD;
&#xD;
          2. All stage of lupus nephritis except stage(i,v,vi)&#xD;
&#xD;
          3. patients who accepted to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with acute inflammatory process such as(rheumatoid arthritis or other&#xD;
             rhumatoligical diseases).&#xD;
&#xD;
          2. Patients who are taking other immunosuppressive therapy.&#xD;
&#xD;
          3. Patients with malignancies.&#xD;
&#xD;
          4. Patients with HCV, HBV or HIV infection.&#xD;
&#xD;
          5. Patients with lupus nephritis sage(i,v,vi).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ALAzhar university</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>May 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 15, 2022</last_update_submitted>
  <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>suzan.D.zakaria</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephritis</mesh_term>
    <mesh_term>Lupus Nephritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Dimethoate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04424602
org study id: 0000085
nct id: NCT04424602
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this work is to study the effect and side effects of the cyclophosphamide versus
      mycophenolate in lupus nephritis
Systemic lupus erythematosus (SLE), also known simply as lupus, is an autoimmune disease in
      which the body's immune system mistakenly attacks healthy tissue in many parts of the body.

      Symptoms vary between people and may be mild to severe. common symptoms include painful and
      swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling
      tired, and a red rash which is most commonly on the face. Often there are periods of illness,
      called flares, and periods of remission during which there are few symptoms.painless passage
      of blood or protein in the urine may often be the only presenting sign of kidney involvement.

      Acute or chronic renal impairment may develop with lupus nephritis, leading to acute or
      end-stage kidney failure. Because of early recognition and management of SLE, end-stage renal
      failure occurs in less than 5% of cases; except in the black population, where the risk is
      many times.Nephritis is the most severe manifestation of lupus. Between 1950s and 1970s,
      corticosteroids were used for the treatment of lupus nephritis (LN) ,and using of
      cyclophosphamide(CPM), improved the outcome dramatically with 5 years survival increasing
      from 17% to 80%.Subsequently, intravenous (iv) CPM became the standard of care in induction
      regimes; however, ivCPM was associated with complications such as bladder toxicity, gonadal
      problems, and infections. To reduce the toxicity, low-dose of 500mg iv(CPM) every two weeks
      for six months showed equivalent efficacy and less side effect.

      Mycophenolatemofetil(MMF) is widely used in solid organ transplantation and it reduces the
      rate of acute rejection following renal transplantation.

      It has also been used to treat patients with other immune-mediated disorders such as
      immunoglobulin A nephropathy, small-vessel vasculitides and psoriasis .

      Lupus nephritisis inflammation of the kidney that is caused by systemic lupus erythematous
      (SLE). Lupus nephritis happens when lupus involves the kidneys.its symptoms, though, are not
      always dramatic. for many, the first noticeable symptom is swelling of the legs, ankles and
      feet. less often, there can be swelling in the face or hands.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study will be carried on40 patients with systemic lupus erythematous with lupus nephritis.the age group of patients will be between 20 to50 years.All lupus nephritis patients will be divided randomly into two groups. First group will be 20female patients on lupus nephritis .They will be given oral corticosteroid( 1mg/kg per day) and intra venous cyclophosphamide 500mg once every two weeks for 6months. Second group will be 20female patients on lupus nephritis they will be given oral corticosteroid(1mg/kg per day) and oral mycophenolat 2 to 3mg/kg for 6 months
primary purpose: Treatment
masking: Single (Participant)
measure: serume creatinine (sCR)
time frame: 6 months
description: to measure treatment response and determine renal function These investigation will be done before starting the pharmacotherapy and after the end of the therapy.its normal range from(0.4 to1.5 mg/dl)its level increase in lupus.
measure: blood uerea nitrogen.
time frame: 6 months
description: to measure treatment response and determine renal function These investigation will be done before starting the pharmacotherapy and after the end of the therapy.its normal range ,around7to20mg/dl(2.5to7.1mmol) its level increase in lupus.
measure: • Erythrocyte sedimentation rate.(ESR)
time frame: 6 months.
description: can help us to determine if patients have inflammation.These investigation will be done before starting the pharmacotherapy and after the end of the therapy .its range from (15to10mm/hr)its level increase in lupus.
measure: • Anti ds DNA
time frame: 6 months
description: will done for diagnosis and ascertain activity of lupusThese investigation will be done before starting the pharmacotherapy and after the end of the therapy if the antidsDNA level are high the lupus may be active and if its level is low the lupus is less active.its rangr(<18iu/ml)
measure: • Complement 3 (C3)
time frame: 6 months
description: will done for diagnosis and ascertain activity of lupus These investigation will be done before starting the pharmacotherapy and after the end of the therapy .c3range from75to175mg/lcomplementc3 level are lower in lupus.
measure: • complete blood count.(CBC)( red blood cells,white blood cells,platelets)
time frame: 6 months
description: to know all information about red blood cells,white blood cells,platelets and effect of two drus on it.These investigation will be done before starting the pharmacotherapy and after the end of the therapy at six months.
measure: • 24h urine test for creatinine clearance and protien excretion.
time frame: 6 months.
description: the test is used to check kideny function.•These investigation will be done before starting the pharmacotherapy and after the end of the therapy.normal urinary protie-to-creatinine ratio is<0.2.
arm group label: cyclophosphamide
arm group type: Experimental
description: participants will receive intra venous cyclophosphamide 500mg once every two weeks for 6months.
arm group label: mycophenolate
arm group type: Active Comparator
description: participants will receive oral mycophenolat 2 to 3mg/kg for 6 months.
intervention type: Drug
intervention name: cyclo phosphamide
description: 500mg vial
arm group label: cyclophosphamide
intervention type: Drug
intervention name: mycophenolate
description: 500mg film-coated tablets.
arm group label: mycophenolate
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Al-Azhar University
investigator full name: suzan.D.zakaria
investigator title: principal investigator
mesh term: Nephritis
mesh term: Lupus Nephritis
mesh term: Cyclophosphamide
mesh term: Dimethoate