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Sponsored by: |
Children's Hospital Medical Center, Cincinnati |
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Information provided by: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT00433953 |
The purpose of this study is to determine how genes influence the response to mycophenolate mofetil (CellCept) in children who have had a kidney transplant. The study will look at how differences in some genes effect blood levels of mycophenolate mofetil over time in children, how often side effects occur and the way that children respond to mycophenolate mofetil.
The results may lead to better dosing based on individual needs.
Condition | Intervention | Phase |
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Kidney Transplant |
Drug: Mycophenolate Mofetil (CellCept) 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: | Pharmacogenetics of Mycophenolic Acid in Kidney Transplant Patients |
Estimated Enrollment: | 50 |
Study Start Date: | February 2007 |
This is an open label, inpatient-outpatient prospective observational study to determine whether the inter-patient variability in mycophenolic acid (MPA) pharmacokinetics and exposure, adverse events and clinical response in pediatric transplant patients (ages 2-18 years) is associated with identifiable pharmacogenetic factors. Specific aims: 1.) To determine whether common polymorphic variations in the uridine diphosphate-glucuronosyltransferases (UGTs) are associated with inter-individual variability in MPA pharmacokinetics and exposure (by affecting MPA metabolism). 2.) To determine whether common polymorphic variations in the uridine diphosphate-glucuronosyltransferases (UGTs) are associated with inter-patient differences in the incidence of adverse events (by affecting the formation of the acyl-glucuronide metabolite). Enrolled subjects will have been receiving mycophenolate mofetil as part of their clinical standard of care. It is anticipated that the clinical portion of the study will last up to 4 hours at one study visit to include one pharmacogenetic blood sample and 4 pharmacokinetic blood samples collected out to 3 hours post-dose. Safety data to be collected will include standard of care physical exam and safety laboratory tests as well as data on adverse events and clinical outcomes.
Ages Eligible for Study: | 2 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Denise Maseck, RN | 513-636-0157 | Denise.Maseck@cchmc.org |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229 | |
Principal Investigator: Alexander A. Vinks, Pharm.D., Ph.D. |
Principal Investigator: | Alexander A. Vinks, Pharm.D., Ph.D. | Children's Hospital Medical Center, Cincinnati |
Study ID Numbers: | TRIPG01 MPA (PG) |
Study First Received: | February 8, 2007 |
Last Updated: | February 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00433953 History of Changes |
Health Authority: | United States: Institutional Review Board |
Pediatric Kidney Transplant Kidney Transplant CellCept Mycophenolate Mofetil Mycophenolic Acid |
Anti-Bacterial Agents Immunologic Factors Mycophenolate mofetil Mycophenolic Acid Immunosuppressive Agents |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Mycophenolate mofetil |
Mycophenolic Acid Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |