Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis
| Condition | Intervention |
|---|---|
|
Nephritis Lupus |
Drug: Leflunomide Drug: Azathioprine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis. |
- lupus nephritis flare [ Time Frame: two years ] [ Designated as safety issue: Yes ]
- 24-hour proteinuria over time [ Time Frame: two years ] [ Designated as safety issue: Yes ]
- Serum albumin over time [ Time Frame: two years ] [ Designated as safety issue: Yes ]
- Number of extra renal flare [ Time Frame: two years ] [ Designated as safety issue: Yes ]
- Cumulated glucocorticoid intake [ Time Frame: two years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Bao Chun De | 086-02158752345 | baochunde_1678@yahoo.com.cn |
| China, Shanghai | |
| RenJi Hospital | Recruiting |
| ShangHai, Shanghai, China, 200001 | |
| Principal Investigator: | Bao Chun De | RenJi Hospital |
More Information
No publications provided
| Responsible Party: | BaoChunde, RenJi Hospital |
| ClinicalTrials.gov Identifier: | NCT01172002 History of Changes |
| Other Study ID Numbers: | RenJiH-20100330 |
| Study First Received: | July 27, 2010 |
| Last Updated: | August 10, 2010 |
| Health Authority: | China: Ethics Committee |
Keywords provided by RenJi Hospital:
|
Lupus Nephritis Leflunomide Azathioprine |
Additional relevant MeSH terms:
|
Glomerulonephritis Lupus Nephritis Nephritis Kidney Diseases Urologic Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Azathioprine Leflunomide |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013