Comparison of the Efficacy of Leflunomide and Azathioprine for the Maintenance Therapy of ANCA Associated Vasculitis

NCT04737343 | Unknown

• 1 other identifier: CSTAR-006
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

ANCA Associated Vasculitis; Maintenance Therapy

Keywords

ANCA Associated Vasculits; Azathioprine; Leflunomide; Maintenance

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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.

  from inclusion to the end of the study, 18 months in total

• Patients progress to ESRD at the end of the study

  from inclusion to the end of the study, 18 months in total

Study Arms (2)

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

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.

Drug: Leflunomide

Interventions

Leflunomide DRUG

Patient will be treated with Leflunomide(Tuoshu, the commericial name) 30mg QD for 18 months

Also known as: Tuoshu for commericial name

Leflunomide treatment arm

Azathioprine Tablets DRUG

Patients included into this study will be treated with Azathioprine tablets 100mg QD for 18 months.

Azathioprine treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese SLE Treatment And Research Group: lead
• Shanghai Zhongshan Hospital: collaborator
• Affiliated Hospital of Jilin University, Changchun,China: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• Sichuan Province People's Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (4)

AnHui provincial hospital

Hefei, Anhui, China

NOT YET RECRUITING

the Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010050, China

NOT YET RECRUITING

the Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

NOT YET RECRUITING

Peking Union Medical College Hospital

Beijing, 100032, China

RECRUITING

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

Leflunomide; Azathioprine

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin 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

• Xinping Tian

  Peking Unione Mdecial College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunjiao Yang, MD

CONTACT

86-13671313079; yangyunjiao81@163.com

Hanqi Wang, RN

CONTACT

86-15810927696; tianxp6@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: prospective, randomized, open-label, control, non-inferiority study

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 3, 2021
• Study Start: June 30, 2021
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)