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Sponsors and Collaborators: |
Children's Hospital Medical Center, Cincinnati Hoffmann-La Roche |
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Information provided by: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT00281619 |
The purpose of this study is to determine how fast children, who have had a recent kidney transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their prescribed dose. The results may lead to better dosing based on individual needs.
Condition | Intervention | Phase |
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Kidney Transplant |
Drug: CellCept (mycophenolate mofetil) Behavioral: Dietary Monitoring Behavioral: Drug Diary Procedure: Blood Sampling |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Development of Population Pharmacokinetic-Pharmacodynamic (PK-PD) Models of Mycophenolic Acid for Bayesian Dose Individualization in Pediatric Kidney Transplant Patients |
Estimated Enrollment: | 24 |
Study Start Date: | January 2006 |
This is an open-label, inpatient-outpatient population pharmacokinetic-pharmacodynamic (PK-PD) study of mycophenolic acid (MPA) in pediatric subjects (age 2-17 years) who have had a recent kidney transplant, as well as during the stable renal transplant period when on a stable oral regimen of MPA. The primary objective of this study is to develop population pharmacokinetic-pharmacodynamic (PK-PD) models for mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) in order to improve individualized pediatric dosing. Subjects will have been receiving CellCept as part of their clinical standard of care. It is anticipated that the clinical portion of the study for each patient will be approximately six months post renal transplant with four study days: a screening visit pre-transplant, two 10-hour inpatient days at 2-3 and 6-9 days post-transplant, and one (up to 10 hour) outpatient visit at 3-6 months post-transplant. Pharmacokinetic and pharmacodynamic measurements will be conducted at various time points (up to 9 hours post dose) on study days 2, 3, and 4. Safety data to be collected will include physical examinations, measurement of vital signs, and laboratory assessments, as well as data on adverse events and clinical outcomes.
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Denise H. Maseck, RN | 513-636-0157 | Denise.Maseck@cchmc.org |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229 | |
Contact: Denise H. Maseck, RN 513-636-0157 Denise.Maseck@cchmc.org | |
Principal Investigator: Alexander A. Vinks, PharmD.,PhD. |
Principal Investigator: | Alexander A. Vinks, PharmD., PhD | Children's Hospital Medical Center, Cincinnati |
Study ID Numbers: | CEL420 MPA (PK-PD), CEL420 |
Study First Received: | January 23, 2006 |
Last Updated: | December 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00281619 |
Health Authority: | United States: Institutional Review Board |
Pediatric Kidney Transplant Kidney Transplant CellCept |
Mycophenolate mofetil Mycophenolic Acid MPA |
Mycophenolate mofetil Mycophenolic Acid |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |