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

Nephritis Clinical Trial

Official title:

MMF Versus Intravenous CTX Pulses in the Treatment of Adult Severe Henoch-Schonlein Purpura Nephritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301613
• Other study ID #: NJCT-0605
• Status: Completed
• Phase: N/A
• First received: March 10, 2006
• Last updated: May 25, 2010
• Start date: January 2003
• Est. completion date: January 2006

Study information

• Verified date: July 2008
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2006
• Est. primary completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Henoch-Schoenlein Purpura
• Nephritis
• Purpura
• Purpura, Schoenlein-Henoch

Intervention

Drug:
• Mycophenolate mofetil
MMF,1.0g/d

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN		12 months	Yes