Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Sponsor

RenJi Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01172002

Collaborator

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

200

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Condition or Disease	Intervention/Treatment	Phase
Nephritis Lupus	Drug: Leflunomide Drug: Azathioprine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

lupus nephritis flare [two years]

Secondary Outcome Measures

24-hour proteinuria over time [two years]
Serum albumin over time [two years]
Number of extra renal flare [two years]
Cumulated glucocorticoid intake [two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RenJi Hospital	ShangHai	Shanghai	China	200001

Sponsors and Collaborators

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

Investigators

Principal Investigator: Bao Chun De, RenJi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01172002

Other Study ID Numbers:

RenJiH-20100330

First Posted:

Jul 29, 2010

Last Update Posted:

Aug 11, 2010

Last Verified:

Aug 1, 2010

Keywords provided by , ,

Lupus Nephritis

Leflunomide

Azathioprine

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2010