Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

NCT01172002 | Unknown DMC

• 1 other identifier: RenJiH-20100330
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Conditions

Nephritis; Lupus

Keywords

Lupus Nephritis; Leflunomide; Azathioprine

Outcome Measures

Primary Outcomes (1)

• lupus nephritis flare

  two years

Secondary Outcomes (4)

• 24-hour proteinuria over time

  two years

• Serum albumin over time

  two years

• Number of extra renal flare

  two years

• Cumulated glucocorticoid intake

  two years

Study Arms (2)

leflunomide group

EXPERIMENTAL

Drug: Leflunomide

Azathioprine group

ACTIVE COMPARATOR

Drug: Azathioprine

Interventions

Leflunomide DRUG

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.

leflunomide group

Azathioprine DRUG

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.

Azathioprine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead
• Changhai Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Zhejiang University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Qilu Hospital of Shandong University: collaborator
• AnHui ShengLi Hospital: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (1)

RenJi Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Related Publications (1)

• Fu Q, Wu C, Dai M, Wang S, Xu J, Dai L, Li Z, He L, Zhu X, Sun L, Lu L, Bao C. Leflunomide versus azathioprine for maintenance therapy of lupus nephritis: a prospective, multicentre, randomised trial and long-term follow-up. Ann Rheum Dis. 2022 Nov;81(11):1549-1555. doi: 10.1136/ard-2022-222486. Epub 2022 Jul 4.

  PMID: 35788493 DERIVED

MeSH Terms

Conditions

Nephritis; Lupus Nephritis

Interventions

Leflunomide; Azathioprine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bao Chun De

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bao Chun De

CONTACT

086-02158752345; baochunde_1678@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 29, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2018
• Last Updated: August 11, 2010

Record last verified: 2010-08

Locations

CN (1)