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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-biopsy | No Intervention | Population in this arm will be adjusted immunosuppressive drug only from the result of tough level. | |
| Protocol biopsy | Experimental | Population in this arm will be adjusted immunosuppressive drug upon both pathological findings and the result of tough level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveillance protocol kidney allograft biopsy | Procedure | Surveillance protocol biopsy under ultrasound-guided will perform at post-operative day 7, month 3, month 6, month 12, and month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function | 24 h-CrCl | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Renal pathology | interstitial fibrosis, rejection, calcineurin inhibitor toxicity | 24 months |
| Complications | hematoma, arteriovenous fistula |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wiwat Chancharoenthana, MD., MSc. | Contact | +66 22564251 | 101 | wiwatmd@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wiwat Chancharoenthana, MD.,MSc. | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University | Recruiting | Bangkok | Bangkok | 10330 | Thailand |
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| immediate, 1 month |