Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients

Astellas

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: Tacrolimus; Drug: cyclosporine microemulsion; Drug: mycophenolate mofetil; Drug: Tacrolimus Modified Release (MR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00064701

02-0-158

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.

Full description

This was a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients at 60 centers in the U.S., Canada and Brazil.

The study consisted of a 1-year post-transplant efficacy and safety study with a clinical continuation phase of a minimum of 2 years or until commercial availability of tacrolimus modified release, unless the Data Safety Monitoring Board or sponsor specified otherwise.

Enrollment: 668 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipient of a primary or retransplanted non-human leukocyte antigen (HLA)-identical living or non-HLA-identical cadaveric kidney transplant
• Age greater or equal to 12 years

Exclusion criteria

• Recipient or donor is known seropositive for human immunodeficiency virus (HIV)
• Has current malignancy or history of malignancy
• Has significant liver disease
• Has uncontrolled concomitant infection or any other unstable medical condition
• Is receiving everolimus or enteric coated mycophenolic acid at any time during the study
• Received kidney with a cold ischemia time of equal or more than 36 hours
• Received kidney transplant from a cadaveric donor equal or more than 60 years of age
• Received intravenous immunoglobulin (IVIG) therapy prior to randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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668 participants in 3 patient groups

Tacrolimus

Experimental group

Description:

Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.

Treatment:

Drug: mycophenolate mofetil

Drug: Tacrolimus

Tacrolimus Modified Release

Active Comparator group

Description:

Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.

Treatment:

Drug: mycophenolate mofetil

Drug: Tacrolimus Modified Release (MR)

Cyclosporine

Active Comparator group

Description:

Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.

Treatment:

Drug: mycophenolate mofetil

Drug: cyclosporine microemulsion