Surveillance Protocol Biopsy
Conditions
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.
Interventions
PROCEDURESurveillance protocol kidney allograft biopsy
Surveillance protocol biopsy under ultrasound-guided will perform at post-operative day 7, month 3, month 6, month 12, and month 24
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* All kidney transplant recipients underwent transplantation at Chulalongkorn University
Exclusion criteria
* Pregnancy * Recipients who cannot withhold aspirin, clopidogrel, warfarin, etc. * Non-cooperated recipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal function | 24 months | 24 h-CrCl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal pathology | 24 months | interstitial fibrosis, rejection, calcineurin inhibitor toxicity |
| Complications | immediate, 1 month | hematoma, arteriovenous fistula |
Countries
Thailand
Contacts
Primary ContactWiwat Chancharoenthana, MD., MSc.
Outcome results
None listed