Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10001024

Enrollment

Unknown

Registered

2010-09-14

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

primary focal segmental glomerulosclerosis

Interventions

group A:intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d

group B:Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Written informed consent; 2. Age 18-75 years old(Including 18 and 75 years); 3. The clinical and renal biopsy confirmed diagnosis of steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis; steroid-resistant: patients who received prednisone or prednisolone(1mg/kg/d) treatment for 12 weeks did not remissionsteroid-dependent: patients relapse when reducted to a certain dose of prednisone; 4. 24h urine protein> 1.5 g, and GFR> 30ml/min.; 5. Those who have not used other than in addition to glucocorticoid immunosuppressant or be discontinued for 3 months; 6. Blood pressure can be controlled over 135/85mmHg.

Exclusion criteria

Exclusion criteria: 1. Secondary FSGS; 2. Application within three months of glucocorticoid were informal; 3. In addition to glucocorticoid, patients have used other immunosuppressant; 4. Blood pressure can not be controlled over 135/85mmHg after antihypertensive treatment; 5. Females who are pregnant or breast-feeding; 6. Patients those with acute renal failure had receives reatment of hemodialysis; 7. Severe infection, heart failure and central nervous system disorders; 8. Severe Immunodeficiency, active gastrointestinal disease, or myelodysplastic; 9. Liver dysfunction cause from other causes; 10. Positive serum parameters for hepatitis B or C; 11. Serum WBC < 3.5×10^9/L, PLT<5*10^12/L; 12. Cancer or an individual history of cancer; 13. Mental illness; 14.Poor compliance, or unwilling to accept treatment in this study.

Design outcomes

Primary

Measure	Time frame
blood and urine routine examination;24-hour urine protein;Serum lipid (Triglyceride, Cholesterol);Liver and kidney function;FK506 concentratio;	—

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