Intracellular and Renal/Myocardial Tissue Concentrations of Cyclosporine A (CsA) and Rejection Frequency Following Transplantation

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

2005-06-30

Study Completion Date

2006-09-30

Brief Summary

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The primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA based immunosuppressive therapy.

Detailed Description

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The primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA based immunosuppressive therapy.

Secondary objectives are to investigate associations between intralymphocyte concentrations and whole-blood concentrations of CsA, renal tissue concentrations and nephrotoxicity, heart tissue concentrations and cardiotoxicity with CsA based immunosuppressive therapy in transplanted patients. In addition, this study aims to validate the use of quinine as a probe for determination of CYP3A4 activity in transplanted patients as well as proteomic-based urine analyses as a screening tool for acute rejection episodes in transplanted patients.

Conditions

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Renal Transplantation Heart Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Cyclosporine A

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Renal or heart transplant recipients scheduled to receive CsA as part of their immunosuppressive therapy at the time of transplantation.
2. 18 years of age or older.
3. Signed informed consent.

Exclusion Criteria

1. Known contraindications for renal or heart biopsies, respectively, at the time of inclusion.
2. Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepine, fluconazole, ketoconazole, erythromycin, clarithromycin.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anders Åsberg, MSc

Role: STUDY_DIRECTOR

University of Oslo

Locations

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Rikshospitalet, Section of Nephrology

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

References

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Loftheim H, Midtvedt K, Hartmann A, Reisaeter AV, Falck P, Holdaas H, Jenssen T, Reubsaet L, Asberg A. Urinary proteomic shotgun approach for identification of potential acute rejection biomarkers in renal transplant recipients. Transplant Res. 2012 Aug 31;1(1):9. doi: 10.1186/2047-1440-1-9.

Reference Type DERIVED

PMID: 23369437 (View on PubMed)

Other Identifiers

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SUPER-CsA

Identifier Type: -

Identifier Source: org_study_id