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

Chulalongkorn University

Status: Unknown

Conditions: Surveillance Protocol Biopsy

Treatments: Procedure: Surveillance protocol kidney allograft biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02294097

WWC-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 17 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Non-biopsy

No Intervention group

Description:

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

Protocol biopsy

Experimental group

Description:

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

Treatment:

Procedure: Surveillance protocol kidney allograft biopsy