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

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ClinicalTrials.gov Identifier: NCT02294097
Recruitment Status : Unknown
Verified November 2014 by Wiwat Chancharoenthana, Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : November 19, 2014
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
Wiwat Chancharoenthana, Chulalongkorn University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Surveillance Protocol Biopsy Procedure: Surveillance protocol kidney allograft biopsy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Outcomes of Protocol-Specified Modification of Immunosuppression Directed to Histological Diagnosis by Surveillance Protocol Biopsy
Study Start Date : November 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Renal function [ Time Frame: 24 months ]
    24 h-CrCl


Secondary Outcome Measures :
  1. Renal pathology [ Time Frame: 24 months ]
    interstitial fibrosis, rejection, calcineurin inhibitor toxicity

  2. Complications [ Time Frame: immediate, 1 month ]
    hematoma, arteriovenous fistula


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294097


Contacts
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Contact: Wiwat Chancharoenthana, MD., MSc. +66 22564251 ext 101 wiwatmd@hotmail.com

Locations
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Thailand
Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Wiwat Chancharoenthana, MD, MSc       wiwatmd@hotmail.com   
Sponsors and Collaborators
Chulalongkorn University
Investigators
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Principal Investigator: Wiwat Chancharoenthana, MD.,MSc. Chulalongkorn University
More Information
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Responsible Party: Wiwat Chancharoenthana, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02294097    
Other Study ID Numbers: WWC-005
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014