Mycophenolate Mofetil (MMF) Versus Intravenous CTX Pulses in the Treatment of Adult Severe HSPN

Not Applicable

Completed

• Conditions: Nephritis; Henoch-Schoenlein Purpura
• Interventions: Drug: Mycophenolate mofetil

• Registration Number: NCT00301613
• Lead Sponsor: Nanjing University School of Medicine

Brief Summary

This study is performed to compare the efficacy, safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN

Detailed Description

Henoch-Schoenlein purpura nephritis (HSPN) with massive proteinuria,renal insufficiency and crescent formation at onset have high risks of progressing to end stage renal failure. Though clinical studies have shown that steroids in combination with cyclophosphamide could reduce proteinuria and preserve renal function, this protocol is associated with many side effects, and is not effective in some patients.

Recent studies have shown that mycophenolic acid(MPA), the active metabolite of mycophenolate mofetil(MMF),could inhibit multifarious effects on endothelial cells, including adhesion molecular expression, neutrophil attachment,IL-6 secretion, and the process of angiogenesis, which contribute to the efficacy of MMF in the treatment of vasculitis. Clinical studies also showed that MMF was effective in the treatment of lupus nephritis with vasculitic lesions. These findings suggest that MMF might be effective in the treatment of severe HSPN, which is a kind of vasculitic lesion. This prospective open-labeled clinical trial study investigates the efficiency of MMF in the treatment of severe HSPN compared with pulse intravenous cyclophosphamide. After 12 months of treatment, we will assess the efficacy, safety, tolerability and relapse of MMF compared with cyclophosphamide in the treatment of severe HSPN.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2005-05
• Study Completion: 2006-01
• Study First Submitted: 2006-03-10
• Study First Submitted QC: 2006-03-10
• Study First Posted: 2006-03-13
• Status Verified: 2008-07
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 16-50 years
• Biopsy proved HSP
• Proteinuria ≥ 3.0 g/24hr
• Scr < 5.0 mg/dl

Exclusion Criteria

• Cytotoxic drug treatment such as CTX, CsA, MMF for morn than 1 month-3 months prior to enrolled
• Pregnancy
• Active/serious infections
• Previous diagnosed diabetes mellitus type 1 or 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mycophenolate mofetil	Mycophenolate mofetil	-

Primary Outcome Measures

Name	Time	Method
To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN	12 months

Trial Locations

Locations (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine; 🇨🇳 Nanjing, Jiangsu, China