Comparative Study of Modified Release (MR) Tacrolimus/MMF in de Novo Kidney Transplant Recipients
Summary
The purpose of this study is to compare the safety and efficacy of Prograf/MMF, Neoral/MMF and Modified Release (MR) Tacrolimus/MMF in de novo kidney transplant recipients.
Description
This will be a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients. Enrollment will include approximately 660 patients at 60-70 centers in the U.S., Canada and South America.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Kidney Transplantation
Intervention
Tacrolimus Modified Release (MR), Tacrolimus, cyclosporine microemulsion, mycophenolate mofetil
Location
Birmingham
Alabama
United States
35294
Status
Completed
Source
Astellas Pharma Inc
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00064701
- Information obtained from ClinicalTrials.gov on December 08, 2011
Medical and Biotech [MESH] Definitions
Tacrolimus Binding Protein 1a
A 12-KDa tacrolimus binding protein that is found associated with and may modulate the function of calcium release channels. It is a peptidyl-prolyl cis/trans isomerase which is inhibited by both tacrolimus (commonly called FK506) and SIROLIMUS.
Tacrolimus Binding Proteins
A family of immunophilin proteins that bind to the immunosuppressive drugs TACROLIMUS (also known as FK506) and SIROLIMUS. EC 5.2.1.-
Tor Serine-threonine Kinases
A serine threonine kinase that controls a wide range of growth-related cellular processes. The protein is referred to as the target of RAPAMYCIN due to the discovery that TACROLIMUS (commonly known as rapamycin) forms an inhibitory complex with TACROLIMUS BINDING PROTEIN 1A that blocks the action of its enzymatic activity.
Immunophilins
Members of a family of highly conserved proteins which are all cis-trans peptidyl-prolyl isomerases (PEPTIDYLPROLYL ISOMERASE). They bind the immunosuppressant drugs CYCLOSPORINE; TACROLIMUS and SIROLIMUS. They possess rotamase activity, which is inhibited by the immunosuppressant drugs that bind to them.
Tacrolimus
A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.
Clinical Trials
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PubMed Articles
Long-term results of prospective randomized trials comparing triple immunosuppressive strategies combining tacrolimus (TAC) or cyclosporine A (CsA) with mycophenolate mofetil (MMF) and steroids after...
The HCV protease inhibitor boceprevir is a strong inhibitor of CYP3A4/5. Cyclosporine and tacrolimus are calcineurin inhibitor immunosuppressants used to prevent organ rejection following liver transp...
Purpose The pharmacokinetics of both tacrolimus and mycophenolic acid in renal transplant recipients on a corticosteroid-free regimen was evaluated. Methods Upon administration of steady-state mornin...
Aim:To evaluate the pharmacokinetics of tacrolimus in Chinese stable liver transplant recipients converted from immediate release (IR) tacrolimus-based immunosuppression to modified release (MR) tacro...
Managing the atazanavir-tacrolimus drug interaction in a renal transplant recipient.
Purpose The management of the drug interaction between atazanavir and tacrolimus in a renal transplant recipient is described. Summary A 53-year-old African-American man with human immunodeficiency vi...
