Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Lupus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01172002
• Other study ID #: RenJiH-20100330
• 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. 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

• Lupus
• Lupus Nephritis
• Nephritis

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