A clinical trial to study the effects of two drugs, Cyclophosphamide and Mycophenolate Mofetil in patients with kidney involvement in Systemic Lupus Erythematosus.

Phase 3

Recruiting

• Conditions: Systemic lupus erythematosus-Lupus nephritis

• Registration Number: CTRI/2013/12/004179
• Lead Sponsor: Dr Manish Rathi

Brief Summary

The study is an open label, prospective, randomized, two-arm, parallel group study aimedat comparing the efficacy and safety of oral Mycophenolate Mofetil for 6 monthswith low-dose intravenous Cyclophosphamide (Euro-Lupus regimen) for threemonths in patients who have a kidney biopsy diagnosis oflupus nephritis (Class III/IV/V). The primary end point is a pre-specifieddecrease in proteinuria and stabilization or improvement in serum creatinine atthe end of induction regimen. Secondary end points include complete renalremission, systemic disease activity (assessed by Safety of Exogenous Estrogensin Lupus Erythematosus National Assessment/Systemic Lupus Erythematosus DiseaseActivity Index) and adverse events at the end of induction regimen. The trialis a non-inferiority trial with the hypothesis that both the drugs performequally good in achieving the target end-points with comparable adversereactions.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-08
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients aged 12 to 65 year with diagnosis of Systemic Lupus Erythematosus by American College of Rheumatology criteria (ACR) 2.
• Kidney biopsy diagnosis of Lupus nephritis class III, IV, V, III+V, IV+V 3.Serum creatinine <3.0 mg/dl.

Exclusion Criteria

• Severe proliferative lupus nephritis on histology (eg.
• Crescentic glomerulonephritis) 2.
• Ongoing infection 3.
• Pregnant females 4.
• Previously received immunosuppressive treatment 5.
• Patient not giving consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-decrease in the urine protein/creatinine ratio to less than 3 in subjects with baseline nephrotic range proteinuria	3 months and six months
-decrease in the urine protein/creatinine ratio by more than 50% in subjects with sub-nephrotic proteinuria (3 urine protein/creatinine ratio).	3 months and six months
-Stabilization of serum creatinine (i.e., a week 24 serum creatinine level ±25% of baseline) or improvement.	3 months and six months

Secondary Outcome Measures

Name	Time	Method
-Complete renal remission, defined as return to normal serum creatinine, proteinuria ≤500mg/24hr and inactive urine sediment	-Systemic disease activity (assessed by Safety of Exogenous Estrogens in Lupus Erythematosus National Assessment/Systemic Lupus Erythematosus Disease Activity Index)

Trial Locations

Locations (1)

Department of Nephrology; 🇮🇳 Chandigarh, CHANDIGARH, India

Department of Nephrology

🇮🇳Chandigarh, CHANDIGARH, India

Dr Manish Rathi

Principal investigator

drmanishrathi@gmail.com