Protocol-Specified Modification of Immunosuppression Directed to Protocol Biopsy in Kidney Transplantation
- Conditions
- Surveillance Protocol Biopsy
- Interventions
- Procedure: Surveillance protocol kidney allograft biopsy
- Registration Number
- NCT02294097
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
The risk-benefit of surveillance-protocol biopsy (SPBx) in kidney transplantation remains unclear. The study aims to compare outcomes of recipients with SPBx approach to recipients with standard approach which allograft biopsy was performed only when indicated.
- Detailed Description
The present randomized-controlled trial in kidney transplant patients aims to compare the outcomes and complications between who underwent immunosuppessive drug modification under surveillance-protocol biopsy and who underwent immunosuppressive drug modification following tough level only.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- All kidney transplant recipients underwent transplantation at Chulalongkorn University
- Pregnancy
- Recipients who cannot withhold aspirin, clopidogrel, warfarin, etc.
- Non-cooperated recipients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Protocol biopsy Surveillance protocol kidney allograft biopsy Population in this arm will be adjusted immunosuppressive drug upon both pathological findings and the result of tough level.
- Primary Outcome Measures
Name Time Method Renal function 24 months 24 h-CrCl
- Secondary Outcome Measures
Name Time Method Renal pathology 24 months interstitial fibrosis, rejection, calcineurin inhibitor toxicity
Complications immediate, 1 month hematoma, arteriovenous fistula
Trial Locations
- Locations (1)
Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
🇹ðŸ‡Bangkok, Thailand