Sirolimus Conversion Efficacy for Graft Function Improvement and Histopathology in Renal Recipients with Mild to Moderate Renal Insufficiency
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0000602
- Lead Sponsor
- Yonsei University Health System
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Age over 18 years
- Patients who administered CNI at least over 3 months
- GFR(Cockcroft-Gault) over 40mL/min and proteinuria under 300mg/day
- Mild and moderate renal insufficiency with stable renal function (variable range of serum creatinine maintained within 20% during 1 month before study enrollment)
- Negative pregnancy test
1. Pancreas transplantation patients
2. Patients who recieved acute rejection treatment within 3 months before registration of this clinical trial
3. Genral or local infection at the screening time
4. Evidence of infiltration, cavitation, or consolidation in chest X-ray at the screening course
5. Unstable angina, threatened arrhythmia that need to be treated
6. Malignancy or PTLD diagnosed within 5 years before registration
7. Administration of other clinical trial medication within 4 weeks before registration
8. Administration of below medicine that affect pharamodynamic of sirolimus: terfenadine, cisapride, astemizole, pimozide, ketoconazole, voriconazole, fluconazole
9. Continuous administration of medicine that affect renal fuction (i.e, aminoglycoside, amphotericin B, cisplatin, etc)
10. Allergic reaction to sirolimus or derivatives from sirolimus
11. WBC count = 3,000/mm3, Platelet = 100,000/ mm3, fasting triglyceride = 400mg/dL, fasting cholesterol = 300mg/dL, fasting HDL-c = 30mg/dL, fasting LDL-c = 200mg/dL
12. Known active B-viral or C-viral hepatitis
13. Known HIV positive patients
14. Pregnant or lactating women
15. Continuing dialysis for more than 8 weeks
16. Patients who underwent major operation within 4 weeks before regisration
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biopsy-proven acute rejection at 12 weeks
- Secondary Outcome Measures
Name Time Method Difference of Banff score between before and after (52 weeks) conversion therapy;Serum creatinine for 52 weeks, GFR and 24hr-urine proteinuria at 4, 12, 28 and 52 weeks;Biopsy-proven acute rejection rate, patient survival rate, and graft survival rate at 52 weeks after conversion;Adverse events incidence: i.e, infection, malignancy, liver function test, lipid profiles