ANCA Associated VasculitisLEFAZAREMNCT04737343
Comparison of the Efficacy of Leflunomide and Azathioprine for the Maintenance Therapy of ANCA Associated Vasculitis
A study testing Leflunomide and Azathioprine Tablets in people with ANCA Associated Vasculitis and Maintenance Therapy, run by Chinese SLE Treatment And Research Group at 4 sites in China.
Trial summary
This study is a prospective, open-labelled, randomized, controlled,multi-center clincial trial. The aim of this study is to verify that the remission rate of patients treated with Leflunomide is not inferior to that of patients treated with Azathioprine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ANCA Associated Vasculitis, Maintenance Therapy
- What is being tested?
- Leflunomide and Azathioprine Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 4 sitesChina
- Study dates
- 30 Jun 2021to 31 Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18 to 75 years, both genders can be included.
- Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis, microscopic polyangiitis, or EGPA in complete remission after combined treatment with glucocorticoids and pulse cyclophosphamide or Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score(BVAS version 3) of 0.
- Patients must fulfill the 1990 ACR classification criteria of GPA, EGPA and 2012 modified Chapel Hill classification criteria of MPA.
- Patients have to be ANCA-positive at diagnosis or during the course of their disease.
- Patients must sign the informed consent.
Who cannot join
- Patients with TPMT gene mutation；
- Patients who had been treated with either AZA or LEF but relapsed in the past;
- Patients who had been treated with either AZA or LEF but had to stop due to adverse events or intolerance;
- Patients who have planned for pregnancy in next 2 years;
- Patients with severe liver dysfunction(defined as the elevation of liver enzyme 3 times the upper limit or Child grade III) or ESRD；
- Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection;
- Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection;
- Patients who are not eligible according to the judge of the principal investigators or site investigators.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100032
Xinping Tian, MD, 86-13691165939, tianxp6@126.com
Hanqi Wang, RN, 86-15810927696, wanghanqi06@163.com
- Not yet recruiting
AnHui provincial hospital
Hefei, Anhui
Li Wang, MD, 86-15055148790, wang_liy@aliyun.com
Xiangpei Li, MD, 86-13515605909, 13515605909@126.com
- Not yet recruiting
the Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010050
Hongbin Li, MD, 13948536552, hongbin.li@cstar.org.cn
Ning Tie, MD, 13948610720, tieting@126.com
- Not yet recruiting
the Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Jian Xu, MD, 13888566797, jian.xu@cstar.org.cn
Shu Li, MD, 15198785584, gglis@126.com
About this study
Official title: The Efficacy of Leflunomide for the Maintenance Therapy of ANCA Associated Vasculitis
This study is a prospective, open-labelled, randomized, controlled,multi-center clincial trial. The aim of this study is to verify that the remission rate of patients treated with Leflunomide is not inferior to that of patients treated with Azathioprine.
Read the detailed description
Background The basic theme of AAV is relapse and remission. The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge. Although many medications have been used for the maintenance of AAV, Leflunomide (LEF) has not studied thoroughly yet. So far, only one study tested the efficacy of LEF in the maintenance therapy for AAV. However, the sample size of this study is small, so large size clinical study is needed to clarify the role of LEF in the maintenance of AAV.
LEF is one of the most frequently prescribed DMARDs in the treatment of rheumatic diseases in China. It is cheap and widely available. Many experiences have been accumulated about its efficacy and safety in Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in the reduction of the relapse of AAV in China. In this study, we try to compare the effectiveness of LEF and AZA, the gold standard for maintenance therapy, in the maintenance of AAV.
Objectives To verify that the effectiveness of LEF in reducing relapse is not inferior to AZA by comparing the relapse rate of LEF and AZA during the 18 month maintenance treatment of AAV.
Study Design This is a prospective, randomized, open-label, control, non-inferiority study.
- Conditions
- ANCA Associated Vasculitis, Maintenance Therapy
- Being tested
- Leflunomide, Azathioprine Tablets
- Keywords
- ANCA Associated Vasculits, Azathioprine, Leflunomide, Maintenance
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeflunomideDrug
Also called Tuoshu for commericial name
Patient will be treated with Leflunomide(Tuoshu, the commericial name) 30mg QD for 18 months
Azathioprine TabletsDrug
Patients included into this study will be treated with Azathioprine tablets 100mg QD for 18 months.
| Study group | Role | What they receive |
|---|---|---|
| Azathioprine treatment arm | Active comparator | Patients will be treated with Azathioprine 100mg QD for 18 months combined with rednisone. The dosage of prednisone is tapered in the study period but will be maintained at 7.5mg/d to the end of the study period.All included patients will be treated with TMPco 2 tablets everyday during the study period if not contraindicated or intoleran.t Receives: Drug: Azathioprine Tablets |
| Leflunomide treatment arm | Experimental | Patient will be treated with Leflunomide 30mg QD for 18 months combined with prednisone. The dosage of prednisone is tapered in the study period but will be maintained at 7.5mg/d to the end of the study period. All included patients will be treated with TMPco 2 tablets everyday during the study period if not contraindicated or intolerant. Receives: Drug: Leflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients with major relapse in 18 months follow-up time
the percentage of patients with major relapse (re-appearance or worsening of disease with a BVAS >0 and involvement of at least one major organ, a life-threatening manifestation, or both) at month 18
Measured: from inclusion to the end of the study, 18 months in total
Secondary outcomes (3)
The rate of minor relapse of the AZA and LEF treatment group in 18 months.
The rate of minor relapse (reappearance or worsening of disease with a BVAS >0, not corresponding to a major relapse but requiring mild treatment intensification) of the AZA and LEF treatment group.
Measured: from inclusion to the end of the study, 18 months in total
The rate of adverse events and their severity in both LEF and AZA treated patients during 18 months of the study period.
- The rate of adverse events and their severity(Severe events were defined as the adverse events of grade 3 or 4, deaths caused by any cause, cancers, side effects that necessitate hospitalization) in both LEF and AZA treated patients during the study period.
Measured: from inclusion to the end of the study, 18 months in total
Patients progress to ESRD at the end of the study
Patients progress to ESRD at the end of the study
Measured: from inclusion to the end of the study, 18 months in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start30 Jun 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA Associated VasculitisStudies of the same condition, open and under way.
- 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
- Model description
- prospective, randomized, open-label, control, non-inferiority study
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Affiliated Hospital of Jilin University, Changchun,China, Second Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Anhui Medical University, Beijing Shijitan Hospital, Capital Medical University, The Affiliated Hospital of Inner Mongolia Medical University, First Affiliated Hospital of Kunming Medical University, Sichuan Province People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Principal investigator, Xinping Tian, Peking Union Medical College Hospital
- Investigators
- Xinping Tian, Principal investigator, Peking Unione Mdecial College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737343
- Sponsor's protocol ID
- CSTAR-006
- Acronym
- LEFAZAREM
- Status last verified
- Nov 2021
- First submitted
- 25 Jan 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only patient clincial information coud be released to public
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Leflunomide for the Maintenance Therapy of ANCA Associated Vasculitis
- ClinicalTrials.gov ID
- NCT04737343
- Acronym / sponsor ID
- LEFAZAREM / CSTAR-006
- Conditions
- ANCA Associated Vasculitis, Maintenance Therapy
- Keywords
- ANCA Associated Vasculits, Azathioprine, Leflunomide, Maintenance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Affiliated Hospital of Jilin University, Changchun,China, Second Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Anhui Medical University, Beijing Shijitan Hospital, Capital Medical University, The Affiliated Hospital of Inner Mongolia Medical University, First Affiliated Hospital of Kunming Medical University, Sichuan Province People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Feb 2021 (actual)
- 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.
This study is a prospective, open-labelled, randomized, controlled,multi-center clincial trial. The aim of this study is to verify that the remission rate of patients treated with Leflunomide is not inferior to that of patients treated with Azathioprine.
Detailed description
Background The basic theme of AAV is relapse and remission. The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge. Although many medications have been used for the maintenance of AAV, Leflunomide (LEF) has not studied thoroughly yet. So far, only one study tested the efficacy of LEF in the maintenance therapy for AAV. However, the sample size of this study is small, so large size clinical study is needed to clarify the role of LEF in the maintenance of AAV.
LEF is one of the most frequently prescribed DMARDs in the treatment of rheumatic diseases in China. It is cheap and widely available. Many experiences have been accumulated about its efficacy and safety in Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in the reduction of the relapse of AAV in China. In this study, we try to compare the effectiveness of LEF and AZA, the gold standard for maintenance therapy, in the maintenance of AAV.
Objectives To verify that the effectiveness of LEF in reducing relapse is not inferior to AZA by comparing the relapse rate of LEF and AZA during the 18 month maintenance treatment of AAV.
Study Design This is a prospective, randomized, open-label, control, non-inferiority study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized, open-label, control, non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Azathioprine treatment arm | Active comparator | Drug: Azathioprine TabletsPatients will be treated with Azathioprine 100mg QD for 18 months combined with rednisone. The dosage of prednisone is tapered in the study period but will be maintained at 7.5mg/d to the end of the study period.All included patients will be treated with TMPco 2 tablets everyday during the study period if not contraindicated or intoleran.t |
| Leflunomide treatment arm | Experimental | Drug: LeflunomidePatient will be treated with Leflunomide 30mg QD for 18 months combined with prednisone. The dosage of prednisone is tapered in the study period but will be maintained at 7.5mg/d to the end of the study period. All included patients will be treated with TMPco 2 tablets everyday during the study period if not contraindicated or intolerant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients age 18 to 75 years, both genders can be included.
- Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis, microscopic polyangiitis, or EGPA in complete remission after combined treatment with glucocorticoids and pulse cyclophosphamide or Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score(BVAS version 3) of 0.
- Patients must fulfill the 1990 ACR classification criteria of GPA, EGPA and 2012 modified Chapel Hill classification criteria of MPA.
- Patients have to be ANCA-positive at diagnosis or during the course of their disease.
- Patients must sign the informed consent.
Key exclusion criteria (8 listed)
- Patients with TPMT gene mutation；
- Patients who had been treated with either AZA or LEF but relapsed in the past;
- Patients who had been treated with either AZA or LEF but had to stop due to adverse events or intolerance;
- Patients who have planned for pregnancy in next 2 years;
- Patients with severe liver dysfunction(defined as the elevation of liver enzyme 3 times the upper limit or Child grade III) or ESRD；
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 |
|---|---|---|
| LeflunomideAlso: Tuoshu for commericial namePatient will be treated with Leflunomide(Tuoshu, the commericial name) 30mg QD for 18 months | Drug | Leflunomide treatment arm |
| Azathioprine TabletsPatients included into this study will be treated with Azathioprine tablets 100mg QD for 18 months. | Drug | Azathioprine treatment arm |
Primary outcome
the percentage of patients with major relapse in 18 months follow-up time
Time frame: from inclusion to the end of the study, 18 months in total
the percentage of patients with major relapse (re-appearance or worsening of disease with a BVAS >0 and involvement of at least one major organ, a life-threatening manifestation, or both) at month 18
3 secondary outcomes
The rate of minor relapse of the AZA and LEF treatment group in 18 months.
Time frame: from inclusion to the end of the study, 18 months in total
The rate of adverse events and their severity in both LEF and AZA treated patients during 18 months of the study period.
Time frame: from inclusion to the end of the study, 18 months in total
Patients progress to ESRD at the end of the study
Time frame: from inclusion to the end of the study, 18 months in total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No. only patient clincial information coud be released to public
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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.
Xinping Tian principal investigator
Peking Unione Mdecial College Hospital
4 sites 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 Tablets in people with ANCA Associated Vasculitis and Maintenance Therapy, run by Chinese SLE Treatment And Research Group at 4 sites 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 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Yunjiao Yang, MD (86-13671313079 ext. 8613671313079, yangyunjiao81@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of patients with major relapse in 18 months follow-up time (time frame: from inclusion to the end of the study, 18 months in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2021.