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

NCT ID: NCT02294097

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surveillance Protocol Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Non-biopsy

Population in this arm will be adjusted immunosuppressive drug only from the result of tough level.

Group Type NO_INTERVENTION

No interventions assigned to this group

Protocol biopsy

Population in this arm will be adjusted immunosuppressive drug upon both pathological findings and the result of tough level.

Group Type EXPERIMENTAL

Surveillance protocol kidney allograft biopsy

Intervention Type PROCEDURE

Surveillance protocol biopsy under ultrasound-guided will perform at post-operative day 7, month 3, month 6, month 12, and month 24

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Wiwat Chancharoenthana

Chulalongkorn University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wiwat Chancharoenthana, MD.,MSc.

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Wiwat Chancharoenthana, MD., MSc.

Role: CONTACT

+66 22564251 ext. 101

Facility Contacts

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Wiwat Chancharoenthana, MD, MSc

Role: primary

Other Identifiers

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WWC-005

Identifier Type: -

Identifier Source: org_study_id