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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00301613

Enrollment

Registered

2006-03-13

Start date

2003-01-31

Completion date

2006-01-31

Last updated

2010-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Henoch-Schoenlein Purpura, Nephritis

Keywords

Henoch-Schonlein purpura nephritis Mycophenolate mofetil, Cyclophosphamide, treatment

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.

Interventions

DRUGMycophenolate mofetil

MMF,1.0g/d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026