Multitarget therapy versus standard Mycophenolate mofetil for induction treatment of Lupus Nephritis : A randomized controlled trial

Phase 4

Recruiting

• Conditions: Disease remission in lupus nephritis patients between 2 drug regimens; Complete remission and time to renal response

• Registration Number: TCTR20200814002
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-14
• Study Completion: 2020-11-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

1. Biopsy proven lupus nephritis class III/IV/V (new case or relapsed)
2. Pathologic chronicity index (CI) < 4
3. At least 24 hr urine protein 1.5 gm/day in LN class III, V
4. Serum creatinine < 2 mg/dl
5. Patient’s informed consent

Exclusion Criteria

1. Disease progression as rapidly progressive glomerulonephritis
2. History of treatment with Methylprednisolone/ Cyclophosphamide/ Mycophenolate mofetil/ Tacrolimus within 12 weeks before enrollment
3. HBV/ HCV/ HIV co-infection
4. Diabetes Mellitus
5. Pregnancy/ Lactation/ Refused contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete remission 24 weeks Clinical and laboratory assessment

Secondary Outcome Measures

Name	Time	Method
Partial remission, overall response rate, time to renal response, safety and adverse effect 24 weeks Clinical and laboratory assessment