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Mycophenolate Mofetil Versus Cyclophosphamide for remission induction Therapy in ANCA Associated Systemic Vasculitiswith renal involvement

Mycophenolate Mofetil Versus Cyclophosphamide for remission induction Therapy in ANCA Associated Systemic Vasculitiswith renal involvement

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000991
Enrollment
Unknown
Registered
2010-08-08
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 Vasculitiswith renal involvement

Interventions

group A:MMF 1.0g/bid (<50kg 0.75g bid)
group B:Intravenous CTX0.5-0.75g/m2 (10-15mg/kg, <1g once)

Sponsors

Shanghai Jiaotong University Affiliated Ruijin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) New diagnosis of AASV (WG, MPA or RLV) (within the previous six months) ; 2) Generalized or severe disease with renal involvement; 3) ANCA positivity; 4) Age 18-80 years old; 5) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Secondary vasculitis caused by drug?SLE or allergic purpura; 2) Known hypersensitivity to MMF, prednisone or CYC; 3) Severe organ dysfunction (immediately life-threatening vasculitis) and renal replcement treatment>2weeks; 4) Severe infection, heart failure and central nervous system disorders; 5) Severe Immunodeficiency, active gastrointestinal disease, or myelodysplastic; 6) Liver dysfunction cause from other causes; 7) Positive serum parameters for hepatitis B or C; 8) WBC< 3*10^9/L; 9) Females who are pregnant, breast feeding, or at risk of pregnancy; 10) Men having a plan for fertility; 11) Mental illness; 12) Cancer or an individual history of cancer; 13) Any condition judged by the investigator that would cause the study to be detrimental to the patient.

Design outcomes

Primary

MeasureTime frame
BVAS;renal function;

Countries

China

Contacts

Public ContactNan Chen
chen-nan@medmail.com.cn+86 021 64370045

Outcome results

None listed

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