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Metabolic Pattern of Cyclosporine A and Acute Renal Failure

NCT ID: NCT00264355

Last Updated: 2007-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Transplantation Acute Renal Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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cyclosporine A

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Heart transplant recipients receiving CsA as part of their immunosuppressive therapy.
* 18 years of age or older.
* Signed informed consent.

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo School of Pharmacy

OTHER

Sponsor Role lead

Principal Investigators

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Anders Åsberg, Ph.D.

Role: STUDY_DIRECTOR

University of Oslo School of Pharmacy

Arnt Fiane, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rikshospitalet, Department of Thoracic surgery

Locations

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Rikshospitalet, Department of Thoracic surgery

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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HeartTx-ARF

Identifier Type: -

Identifier Source: org_study_id