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A Prospective Randomized Study on the Efficacy of Steroid combined with CTX or Tacrolimus in IMN Patients with NS

A Prospective Randomized Study on the Efficacy of Steroid combined with CTX or Tacrolimus in IMN Patients with NS

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001144
Enrollment
Unknown
Registered
2011-01-02
Start date
2008-01-01
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

Idiopathic membranous nephropathy

Interventions

CTX:CTX 0.5-0.75g/m2, max 1g, pred 1mg/kg/d 65y, pred 0.5mg/kg/d
for 12 months
FK 506:FK506 0.1mg/kg/d, for 12months, pred 0.5mg/kg/d

Sponsors

Shanghai Jiaotong University Affiliated Ruijin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Idiopathic membranous nephropathy patients proven by biopsy within 24 weeks; (2) 24-hour urinary protein excretion at admission no less than 5g or serum albumin less than 25g/L; (3) The patient had renal insufficiency defined as CKD 2~3 stage with moderate proteinuria or severe NS with pleural effusion, ascites, renal venous thrombosis; (4) NS patients without severe edma, follow-up 3 months,24-hour urinary protein excretion more than 5g or serum albumin less than 25g/L; (5) Written informed consent.

Exclusion criteria

Exclusion criteria: (1) Secondary membranous nephropathy,including Lupus, Malignancy, Hepatitis B virus infection,drug induced; (2) Patients used immunosuppressive therapy including FK506, MMF, CTX, CsA within 3 months; (3) Known hypersensitivity to KF506, prednisone or CTX; (4) Severe infection, heart failure and central nervous system disorders; (5) Severe Immunodeficiency, active gastrointestinal disease, or myelodysplastic; (6) Females who are pregnant, breast feeding, or at risk of pregnancy; (7) Positive serum parameters for hepatitis B; (8) Patients with poor compliance by medical staff; (9) Post renal transplantation.

Design outcomes

Primary

MeasureTime frame
24-hour urinary protein excretion;Serum albumin;serum creatine;

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