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Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2010 by RenJi Hospital
Sponsor:
Collaborators:
Changhai Hospital
Shanghai 10th People's Hospital
Shanghai Zhongshan Hospital
Jiangsu Province Hospital
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
Wenzhou Medical University
Qilu Hospital
AnHui ShengLi Hospital
First Affiliated Hospital Bengbu Medical College
The First Affiliated Hospital of Anhui Medical University
Information provided by:
RenJi Hospital
ClinicalTrials.gov Identifier:
NCT01172002
First received: July 27, 2010
Last updated: August 10, 2010
Last verified: August 2010
  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.

Resource links provided by NLM:


Further study details as provided by RenJi Hospital:

Primary Outcome Measures:
  • lupus nephritis flare [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Jiangsu Province Hospital
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
Wenzhou Medical University
Qilu Hospital
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

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

ClinicalTrials.gov processed this record on November 27, 2014