Sirolimus Conversion Efficacy for Graft Function Improvement and Histopathology in Renal Recipients with Mild to Moderate Renal Insufficiency

An open-label, two-center study evaluating the safety and efficacy of converting from calcineurin inhibitors to sirolimus in renal allograft recipients with mild to moderate renal insufficiency

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000602

Enrollment

Registered

2012-12-12

Start date

2007-03-26

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : 1) CNI reduction : Reduction started in the first day of conversion treatment with 25% off of CNI dosage in a week for 4 weeks and cessation of CNI after 4 weeks. 2) SRL: Loading dose of SRL (

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Biopsy-proven acute rejection at 12 weeks	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactDong Jin Joo

Yonsei University Health System

Outcome results