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Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT01172002
Recruitment Status : Recruiting
First Posted : July 29, 2010
Last Update Posted : August 11, 2010
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Condition or disease Intervention/treatment
Nephritis Lupus Drug: Leflunomide Drug: Azathioprine

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  (Clinical Trial)
Estimated 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 : March 2010
Estimated Primary Completion Date : June 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.



Outcome Measures

Primary Outcome Measures :
  1. lupus nephritis flare [ Time Frame: two years ]

Secondary Outcome Measures :
  1. 24-hour proteinuria over time [ Time Frame: two years ]
  2. Serum albumin over time [ Time Frame: two years ]
  3. Number of extra renal flare [ Time Frame: two years ]
  4. Cumulated glucocorticoid intake [ Time Frame: two years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172002


Contacts
Contact: Bao Chun De 086-02158752345 baochunde_1678@yahoo.com.cn

Locations
China, Shanghai
RenJi Hospital Recruiting
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 Univeristy
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
More Information

Responsible Party: BaoChunde, RenJi Hospital
ClinicalTrials.gov Identifier: NCT01172002     History of Changes
Other Study ID Numbers: RenJiH-20100330
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: August 2010

Keywords provided by RenJi Hospital:
Lupus Nephritis
Leflunomide
Azathioprine

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Azathioprine
Leflunomide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors