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

November 15, 2014 updated by: Wiwat Chancharoenthana, Chulalongkorn University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non-biopsy
Population in this arm will be adjusted immunosuppressive drug only from the result of tough level.
Experimental: Protocol biopsy
Population in this arm will be adjusted immunosuppressive drug upon both pathological findings and the result of tough level.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function
Time Frame: 24 months
24 h-CrCl
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal pathology
Time Frame: 24 months
interstitial fibrosis, rejection, calcineurin inhibitor toxicity
24 months
Complications
Time Frame: immediate, 1 month
hematoma, arteriovenous fistula
immediate, 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Wiwat Chancharoenthana, MD.,MSc., Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 15, 2014

First Submitted That Met QC Criteria

November 15, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 15, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • WWC-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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