Back to results

Metabolic Pattern of Cyclosporine A and Acute Renal Failure

Primary Purpose

Heart Transplantation, Acute Renal Failure

Status

Completed

Phase

Phase 4

Locations

Norway

Study Type

Interventional

Intervention

cyclosporine A

About this trial

This is an interventional diagnostic trial for Heart Transplantation focused on measuring cyclosporine, metabolites, metabolic pattern, genotypes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rikshospitalet, Department of Thoracic surgery

Outcomes

Primary Outcome Measures

The primary analysis of cyclosporine and metabolite concentrations and ratios will be compared between the patients developing acute renal failure and those who do not

Secondary Outcome Measures

Regression analysis comparing concentrations/ratios and actual renal function (continuously parameter)

Descriptive listing of cyclosporine and metabolites concentrations in CYP3A5*3/*3 patients compared to the other patients. It is anticipated that an exploratory analysis will be performed to compare the two groups.

Descriptive listing of CsA and metabolites concentrations in patients with different combinations of MDR-1 genotypes compared to the other patients. It is anticipated that an exploratory analysis will be performed to compare the two groups.

Full Information

NCT ID

NCT00264355

First Posted

December 9, 2005

Last Updated

September 5, 2007

Sponsor

University of Oslo School of Pharmacy

1. Study Identification

Unique Protocol Identification Number

NCT00264355

Brief Title

Metabolic Pattern of Cyclosporine A and Acute Renal Failure

Official Title

Metabolic Pattern of Cyclosporine A - Association of Secondary- and Cyclic Metabolites With Acute Renal Failure in Heart Transplant Recipients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Oslo School of Pharmacy

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Transplantation, Acute Renal Failure

Keywords

cyclosporine, metabolites, metabolic pattern, genotypes

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cyclosporine A

Primary Outcome Measure Information:

Title

The primary analysis of cyclosporine and metabolite concentrations and ratios will be compared between the patients developing acute renal failure and those who do not

Secondary Outcome Measure Information:

Title

Regression analysis comparing concentrations/ratios and actual renal function (continuously parameter)

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anders Åsberg, Ph.D.

Organizational Affiliation

University of Oslo School of Pharmacy

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Arnt Fiane, MD, Ph.D.

Organizational Affiliation

Rikshospitalet, Department of Thoracic surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rikshospitalet, Department of Thoracic surgery

City

Oslo

ZIP/Postal Code

Oslo

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

Metabolic Pattern of Cyclosporine A and Acute Renal Failure

We'll reach out to this number within 24 hrs