Comparison between2 Drugs in Lupus Nephritis
Primary Purpose
Lupus Nephritis
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
cyclo phosphamide
mycophenolate
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis
Eligibility Criteria
Inclusion Criteria:
- All patients have systemic lupus erythromatosis with lupus nephritis either newly diagnosed or with history of SLE with lupus nephrits
- All stage of lupus nephritis except stage(i,v,vi)
- patients who accepted to participate in the study.
Exclusion Criteria:
- Patient with acute inflammatory process such as(rheumatoid arthritis or other rhumatoligical diseases).
- Patients who are taking other immunosuppressive therapy.
- Patients with malignancies.
- Patients with HCV, HBV or HIV infection.
- Patients with lupus nephritis sage(i,v,vi).
Sites / Locations
- ALAzhar university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cyclophosphamide
mycophenolate
Arm Description
participants will receive intra venous cyclophosphamide 500mg once every two weeks for 6months.
participants will receive oral mycophenolat 2 to 3mg/kg for 6 months.
Outcomes
Primary Outcome Measures
serume creatinine (sCR)
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.
blood uerea nitrogen.
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.
• Erythrocyte sedimentation rate.(ESR)
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.
• Anti ds DNA
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)
• Complement 3 (C3)
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.
• complete blood count.(CBC)( red blood cells,white blood cells,platelets)
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.
• 24h urine test for creatinine clearance and protien excretion.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04424602
Brief Title
Comparison between2 Drugs in Lupus Nephritis
Official Title
Comparison Between Mycophenolate andCyclophosphamide in the Treatment of Lupus Nephritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
September 5, 2021 (Actual)
Study Completion Date
September 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this work is to study the effect and side effects of the cyclophosphamide versus mycophenolate in lupus nephritis
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cyclophosphamide
Arm Type
Experimental
Arm Description
participants will receive intra venous cyclophosphamide 500mg once every two weeks for 6months.
Arm Title
mycophenolate
Arm Type
Active Comparator
Arm Description
participants will receive oral mycophenolat 2 to 3mg/kg for 6 months.
Intervention Type
Drug
Intervention Name(s)
cyclo phosphamide
Intervention Description
500mg vial
Intervention Type
Drug
Intervention Name(s)
mycophenolate
Intervention Description
500mg film-coated tablets.
Primary Outcome Measure Information:
Title
serume creatinine (sCR)
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.
Time Frame
6 months
Title
blood uerea nitrogen.
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.
Time Frame
6 months
Title
• Erythrocyte sedimentation rate.(ESR)
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.
Time Frame
6 months.
Title
• Anti ds DNA
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)
Time Frame
6 months
Title
• Complement 3 (C3)
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.
Time Frame
6 months
Title
• complete blood count.(CBC)( red blood cells,white blood cells,platelets)
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.
Time Frame
6 months
Title
• 24h urine test for creatinine clearance and protien excretion.
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.
Time Frame
6 months.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients have systemic lupus erythromatosis with lupus nephritis either newly diagnosed or with history of SLE with lupus nephrits
All stage of lupus nephritis except stage(i,v,vi)
patients who accepted to participate in the study.
Exclusion Criteria:
Patient with acute inflammatory process such as(rheumatoid arthritis or other rhumatoligical diseases).
Patients who are taking other immunosuppressive therapy.
Patients with malignancies.
Patients with HCV, HBV or HIV infection.
Patients with lupus nephritis sage(i,v,vi).
Facility Information:
Facility Name
ALAzhar university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Comparison between2 Drugs in Lupus Nephritis
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