CClinicalTrials.gg
Sign In
Status unknownNCT01172002Updated Aug 11, 2010

Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

An interventional study of Leflunomide and Azathioprine in Nephritis and Lupus, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-08-11.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Read the 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.

02

Conditions studied

  • Nephritis
  • Lupus

Keywords

  • Lupus Nephritis
  • Leflunomide
  • Azathioprine
03

In context

Nephritis

245 studies on the registry are indexed under Nephritis; 56 are open to participants now.

This study's planned enrollment of 200 is above the median of 49 across 156 interventional studies indexed under Nephritis.

Browse Nephritis studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    leflunomide group

    Drug: Leflunomide

  • Active comparator
    Azathioprine group

    Drug: Azathioprine

Interventions

  • DrugLeflunomide

    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.

  • DrugAzathioprine

    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.

06

What researchers measure

Primary outcomes

  1. lupus nephritis flare

    Time frame: two years

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • RenJi Hospital
    ShangHai, Shanghai 200001, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 35788493 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01172002
Lead sponsor
RenJi Hospital
Collaborators
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 University, Qilu Hospital of Shandong University, AnHui ShengLi Hospital, First Affiliated Hospital Bengbu Medical College, The First Affiliated Hospital of Anhui Medical University
First posted
Jul 29, 2010
Start date
Mar 2010
Primary completion
Jun 2018 (estimated)
Last update
Aug 11, 2010

Study contacts

Bao Chun De
Contact
baochunde_1678@yahoo.com.cn
086-02158752345
Bao Chun De
principal investigator · RenJi Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Nephritis→

Other studies from this sponsor

RenJi Hospital

Start the discussion