Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

August 10, 2010 updated by: RenJi Hospital

A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.

Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Proliferative glomerulonephritis is a common and severe manifestation of systemic lupus erythematosus (SLE) that usually requires intensive therapy with high doses of glucocorticosteroids and cytotoxic drugs, such as intravenous (IV) cyclophosphamide (CYC). The objective of this Trial is to compare leflunomide (LEF) and azathioprine (AZA), in terms of efficacy and toxicity, as remission-maintaining treatment of proliferative lupus glomerulonephritis, after a remission-inducing therapy with a short-course IV CYC regimen. The hypothesis of this trial is that LEF is non-inferior to AZA.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • ShangHai, Shanghai, China, 200001
        • Recruiting
        • RenJi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 to 65 years
  • Biopsy-proven proliferative lupus nephritis
  • Disease activity, SLEDAI score ≥ 8 points
  • Persistent proteinuria (≥ 1g/24h), with or without microscopic hematuria;
  • Signed informed consent

Exclusion Criteria:

  • Allergy to the LEF, CTX, AZA
  • Recent treatment with high-dose glucocorticoids
  • Weight <45kg
  • Recent treatment with immunosuppressive drugs
  • CNS( Central Nerve System) Lupus patients
  • Hepatic failure patients
  • Severely abnormal renal function or end-stage renal failure
  • More exclusion criteria in the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: leflunomide group
Drug: Leflunomide

Leflunomide, 20 mg/d, ORAL ,each day. Number of Cycles: until progression or unacceptable toxicity develops.

Predonine, 10 mg/d, ORAL, each day. If extra renal flare occurs, the dose of predonine may be increased to 1mg/kg/day for not more than 2 weeks.
Active Comparator: Azathioprine group
Drug: Azathioprine

Azathioprine,50-100 mg/d, ORAL ,each day . Number of Cycles: until progression or unacceptable toxicity develops.

Predonine, 10 mg/d, ORAL, each day. If extra renal flare occurs, the dose of predonine may be increased to 1mg/kg/day for not more than 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lupus nephritis flare
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
24-hour proteinuria over time
Time Frame: two years
two years
Serum albumin over time
Time Frame: two years
two years
Number of extra renal flare
Time Frame: two years
two years
Cumulated glucocorticoid intake
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

The First Affiliated Hospital with Nanjing Medical University
Changhai Hospital
The First Affiliated Hospital of Anhui Medical University
Shanghai Zhongshan Hospital
Qilu Hospital of Shandong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Shanghai 10th People's Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The First Affiliated Hospital of Soochow University
Zhejiang University
First Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital Bengbu Medical College
AnHui ShengLi Hospital

Investigators

  • Principal Investigator: Bao Chun De, RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 28, 2010

First Posted (Estimate)

July 29, 2010

Study Record Updates

Last Update Posted (Estimate)

August 11, 2010

Last Update Submitted That Met QC Criteria

August 10, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-20100330

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nephritis

Clinical Trials on Leflunomide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe