Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

Astellas

Status and phase: Terminated; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: mycophenolate mofetil; Drug: Prednisone; Drug: Tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00133172

FKC-011

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
• Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
• Subject is 18 years of age or over at the time of 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 60 years of age or older
• Recipients of donation after cardiac death (DCD) donors
• Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
• Subjects with a second renal allograft who had their original graft for < 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
• Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) >20
• Subjects with hepatitis B & C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
• Subjects receiving an allograft with cold ischemia time 24 hours or greater
• Subjects who have received an investigational drug within three months prior to randomization
• Subjects who are breastfeeding
• Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
• Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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85 participants in 2 patient groups

1

Experimental group

Description:

Steroid rapid 5-day withdrawal

Treatment:

Drug: Prednisone

Drug: Tacrolimus

Drug: mycophenolate mofetil

2

Active Comparator group

Description:

Standard steroid maintenance

Treatment:

Drug: Prednisone

Drug: Tacrolimus

Drug: mycophenolate mofetil