NephritisNCT01172002
Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
A study testing Leflunomide and Azathioprine in people with Nephritis and Lupus, run by RenJi Hospital at 1 site in China.
Trial summary
Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Leflunomide and Azathioprine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
RenJi Hospital
Shanghai, Shanghai Municipality, 200001
About this study
Official title: A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.
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.
- Being tested
- Leflunomide, Azathioprine
- Keywords
- Lupus Nephritis, Leflunomide, Azathioprine
- Medical subject headings
- Nephritis, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeflunomideDrug
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.
AzathioprineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| leflunomide group | Experimental | Not described Receives: Drug: Leflunomide |
| Azathioprine group | Active comparator | Not described Receives: Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
lupus nephritis flare
Measured: two years
Secondary outcomes (4)
24-hour proteinuria over time
Measured: two years
Serum albumin over time
Measured: two years
Number of extra renal flare
Measured: two years
Cumulated glucocorticoid intake
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephritisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- 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, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital of Wenzhou Medical University, Qilu Hospital of Shandong University, AnHui ShengLi Hospital, The First Affiliated Hospital of Bengbu Medical University, The First Affiliated Hospital of Anhui Medical University
- Investigators
- Bao Chun De, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172002
- Sponsor's protocol ID
- RenJiH-20100330
- Status last verified
- Aug 2010
- First submitted
- 27 Jul 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.
- ClinicalTrials.gov ID
- NCT01172002
- Acronym / sponsor ID
- RenJiH-20100330
- Keywords
- Lupus Nephritis, Leflunomide, Azathioprine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- 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, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital of Wenzhou Medical University, Qilu Hospital of Shandong University, AnHui ShengLi Hospital, The First Affiliated Hospital of Bengbu Medical University, The First Affiliated Hospital of Anhui Medical University
- Study start
- Mar 2010
- Primary completion
- Jun 2018 (estimated)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| leflunomide group | Experimental | Drug: Leflunomide |
| Azathioprine group | Active comparator | Drug: Azathioprine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeflunomideLeflunomide, 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. | Drug | leflunomide group |
| AzathioprineAzathioprine,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. | Drug | Azathioprine group |
Primary outcome
lupus nephritis flare
Time frame: two years
4 secondary outcomes
24-hour proteinuria over time
Time frame: two years
Serum albumin over time
Time frame: two years
Number of extra renal flare
Time frame: two years
Cumulated glucocorticoid intake
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
- Derived from this study: PubMed 35788493Fu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bao Chun De principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leflunomide and Azathioprine in people with Nephritis and Lupus, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bao Chun De (086-02158752345, baochunde_1678@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lupus nephritis flare (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01172002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2010.