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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01172002
Other study ID # RenJiH-20100330
Secondary ID
Status Recruiting
Phase N/A
First received July 27, 2010
Last updated August 10, 2010
Start date March 2010

Study information

Verified date August 2010
Source RenJi Hospital
Contact Bao Chun De
Phone 086-02158752345
Email baochunde_1678@yahoo.com.cn
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
China RenJi Hospital ShangHai Shanghai

Sponsors (14)

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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary lupus nephritis flare two years Yes
Secondary 24-hour proteinuria over time two years Yes
Secondary Serum albumin over time two years Yes
Secondary Number of extra renal flare two years Yes
Secondary Cumulated glucocorticoid intake two years Yes
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