Mycophenolate Mofetil Versus Cyclophosphamide Versus Leflunomide for Maintenance Therapy in ANCA Associated Systemic Vasculitis with renal involvement in remission

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10000990

Enrollment

Unknown

Registered

2010-07-17

Start date

2009-01-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ANCA Associated Systemic Vasculitis with renal involvement in remission

Interventions

group A:CTX 10-15mg/kg, 2, 4, 6, 9, 12, 18, 24month

group B:MMF1.5-2.0g/d, reduced by 500mg every 3 months from

group C:Leflunomide 20mg/d, reduced by 10mg every 3 months

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) AASV (WG, MPA or RLV) in remission that has been induced by CTX or MMF; generalized or severe disease with renal involvement; 2) ANCA positivity ; 3) Not caused by drug or SLE; 4) eGFR>=30ml/min,Scr<500umol/l; 5) Age 18-80 years old.

Exclusion criteria

Exclusion criteria: 1) Myelodysplastic, Immunodeficiency or active Gastrointestinal disease; 2) Co-existence of another systemic autoimmune disease, e.g. SLE; 3) Idiopathic interstitial pneumonia (not attributed to vasculitis); 4) Active infection (including hepatitis B, C). 5) Females who are pregnant, breast feeding, or at risk of pregnancy; 6) eGFR500umol/l; 7) Any condition judged by the investigator that would cause the study to be detrimental to the patient.

Design outcomes

Primary

Measure	Time frame
relapse rate;	—

Secondary

Measure	Time frame
EKG;BVAS;liver and renal function;proteinuria/24hrs;blood routine;ANCA;CR;CRP;ESR;urine routin;	—

Countries

China

Contacts

Public ContactNan Chen

chen-nan@medmail.com.cn+86 021 64370045-665232

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026