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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Research of Standard Diagnosis and Treatment for HSPN in Children

NCT02532777

Henoch-Schoenlein Purpura Nephritis

UNKNOWN PHASE2

Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

NCT05951517

Henoch-Schönlein Purpura Gastrointestinal Injury Mycophenolate Mofetil

RECRUITING NA

MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis

NCT00301652

Vasculitis Anti-Neutrophil Cytoplasmic Antibody

COMPLETED NA

The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children

NCT02532790

Henoch-Schoenlein Purpura Nephritis

UNKNOWN PHASE2

Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy

NCT00301600

IGA Nephropathy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Henoch-Schoenlein Purpura Nephritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mycophenolate mofetil

Group Type ACTIVE_COMPARATOR

Mycophenolate mofetil

Intervention Type DRUG

MMF,1.0g/d

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mycophenolate mofetil

MMF,1.0g/d

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mycophenolate mofetil,cellcept

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes