Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Oslo School of Pharmacy |
---|---|
Information provided by: | University of Oslo School of Pharmacy |
ClinicalTrials.gov Identifier: | NCT00264355 |
Following heart transplantation many patients develop acute renal failure in the early posttransplant phase and some are in need of renal replacement therapy for shorter or longer time. The cause of this acute renal failure is most probably multi factorial but many reports indicate that cyclosporine has a central role in the pathophysiology and it is generally recommended to lower the cyclosporine load to patients developing acute renal failure in this population.
Several in vitro studies on renal cells in culture indicate that the primary metabolites of cyclosporine (AM1, AM9, AM4N) are less toxic to the kidney than cyclosporine itself. However, the secondary metabolite AM19 as well as the cyclic metabolites AM1c and AM1c9 has been associated with decreased renal function and nephrotoxicity renal transplant recipients.
The primary objective of this pilot study is to investigate if the concentrations of secondary- and cyclic metabolites of cyclosporine (AM19, AM1c, AM1c9) is related to development of acute renal failure in the early posttransplant phase following heart transplantation.
Secondary objectives are to investigate associations between genotypes of P-glycoprotein and CYP3A5 and the metabolic pattern of cyclosporine.
Condition | Intervention | Phase |
---|---|---|
Heart Transplantation Acute Renal Failure |
Drug: cyclosporine A |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Metabolic Pattern of Cyclosporine A - Association of Secondary- and Cyclic Metabolites With Acute Renal Failure in Heart Transplant Recipients |
Estimated Enrollment: | 30 |
Study Start Date: | December 2005 |
Study Completion Date: | June 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Rikshospitalet, Department of Thoracic surgery | |
Oslo, Norway, Oslo |
Study Director: | Anders Åsberg, Ph.D. | University of Oslo School of Pharmacy |
Principal Investigator: | Arnt Fiane, MD, Ph.D. | Rikshospitalet, Department of Thoracic surgery |
Study ID Numbers: | HeartTx-ARF |
Study First Received: | December 9, 2005 |
Last Updated: | September 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00264355 |
Health Authority: | Norway: Norwegian Medicines Agency |
cyclosporine metabolites metabolic pattern genotypes |
Renal Insufficiency Cyclosporine Urologic Diseases Clotrimazole Miconazole Tioconazole |
Neoplasm Metastasis Renal Insufficiency, Acute Kidney Diseases Kidney Failure, Acute Cyclosporins Kidney Failure |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antifungal Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Pharmacologic Actions |