Clinical trial NCT01172002: Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
Official title: A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nephritis
Lupus
Keywords: Lupus Nephritis
Leflunomide
Azathioprine
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Shanghai 10th People's Hospital
name: Shanghai Zhongshan Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: The First Affiliated Hospital of Soochow University
name: Zhejiang University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: First Affiliated Hospital of Wenzhou Medical University
name: Qilu Hospital of Shandong University
name: AnHui ShengLi Hospital
name: The First Affiliated Hospital of Bengbu Medical University
name: The First Affiliated Hospital of Anhui Medical University
First posted: 2010-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis

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 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

Primary outcomes:
measure: lupus nephritis flare
timeFrame: two years
Secondary outcomes:
measure: 24-hour proteinuria over time
timeFrame: two years
measure: Serum albumin over time
timeFrame: two years
measure: Number of extra renal flare
timeFrame: two years
measure: Cumulated glucocorticoid intake
timeFrame: two years
Other outcomes:
Locations:
city: ShangHai
country: China
facility: RenJi Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Bao Chun De
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.