Pharmacokinetic Studies of Tacrolimus in Transplant Patients

University Of Cincinnati, Cincinnati OH

Investigators

Linked publications & trials

Abstract

Summary Rita R. Alloway, PharmD, FCCP is the Director of Transplant Clinical Research for the University of Cincinnati and a Research Professor of Medicine. Dr. Alloway, together with Drs Christians and Sander, will design, coordinate the study, design study database, analyze, interpret and publish the data. This is an open label, prospective, multicenter, randomized, replicate, six-period, six-sequence cross-over study to compare the steady state pharmacokinetics of Prograf to Generic Hi to Generic Lo in stable renal (n=36) and liver transplant (n=36) subjects. The two generic products selected will be the most disparate generics as determined by evaluation of healthy volunteer ABE data along with product dissolution, potency, and impurity testing. The test products will be blinded by over encapsulation. The PK assessor will be blinded to the assigned treatment sequence and formulation. The person analyzing the levels and analyzing the results will be blinded to formulation sequence. Dr. Alloway will interface with the University of Iowa Pharmaceuticals group for selection and preparation of final study product, and the University Hospital Investigational Drug Services to facilitate timely study product availability to meet strict study timelines. In her role as PI, Dr. Alloway is responsible for the overall study conduct. She will oversee the study conduct, data and sample collection, clarification of date entry, and compliant data handling. She will work with Drs. Shields, Kaiser, Woodle, Cardi and Sherman to facilitate study conduct by supervising the pharmacokinetic portion of the trial via adherence assessments and time sampling compliance. She will interface with the Children's Medical Center group for proper analysis and collection of MEMS cap data during the study to quantitate patient adherence. From a management perspective, she will manage the research coordinator staff to assure proper study conduct which will include proper sample collection, handling and shipping subject samples to the University of Colorado for analysis. Upon completion of tacrolimus level analysis, data will be provided to Dr. Sander Vinks for analysis of PK variables. In addition, Dr. Alloway will facilitate the interface with the CCTST and the coordinators in building the study database in REDCap, coordinating efforts with the statisticians to assure proper data handling, and completion of annual and final study reports/manuscripts.