Protocol-Specified Modification of Immunosuppression Directed to Protocol Biopsy in Kidney Transplantation

Surveillance Protocol Biopsy Clinical Trial

Official title:

The Outcomes of Protocol-Specified Modification of Immunosuppression Directed to Histological Diagnosis by Surveillance Protocol Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02294097
• Other study ID #: WWC-005
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2014
• Last updated: November 15, 2014
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2014
• Source: Chulalongkorn University
• Contact: Wiwat Chancharoenthana, MD., MSc.
• Phone: +66 22564251
• Email: wiwatmd[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Research Institute for Health Sciences
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surveillance Protocol Biopsy

Intervention

Procedure:
• Surveillance 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

Locations

Country	Name	City	State
Thailand	Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function	24 h-CrCl	24 months	No
Secondary	Renal pathology	interstitial fibrosis, rejection, calcineurin inhibitor toxicity	24 months	No
Secondary	Complications	hematoma, arteriovenous fistula	immediate, 1 month	Yes