Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

Astellas

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Tacrolimus; Drug: Corticosteroids (Prednisone); Drug: MMF

Study type: Interventional

Funder types: Industry

Identifiers

NCT00885820

FKC-008

Details and patient eligibility

About

This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant
• If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion criteria

• Recipients of a kidney from a donor over 65 years of age
• Recipient of non-related donor kidney with peak pre-transplant PRA > 50
• Subject has lost a previous graft to rejection less than one year from transplant
• Subject who has received an investigational drug within three months prior to randomization
• Subjects who are pregnant or breastfeeding
• Subject receives a kidney lacking a pre-implantation biopsy
• Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

1

Experimental group

Description:

Protocol biopsies at 1, 2 and 3 months

Treatment:

Drug: MMF

Drug: Corticosteroids (Prednisone)

Drug: Tacrolimus

2

Active Comparator group

Description:

No protocol biopsies

Treatment:

Drug: MMF

Drug: Corticosteroids (Prednisone)

Drug: Tacrolimus