ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00139009
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : June 15, 2007
Sponsor:
Information provided by:
University of Oslo School of Pharmacy

August 29, 2005
August 30, 2005
June 15, 2007
June 2005
Not Provided
  • rejection
  • pharmacokinetics
Same as current
Complete list of historical versions of study NCT00139009 on ClinicalTrials.gov Archive Site
  • toxicity
  • genotypes
  • metabolites
Same as current
Not Provided
Not Provided
 
Intracellular and Renal/Myocardial Tissue Concentrations of Cyclosporine A (CsA) and Rejection Frequency Following Transplantation
Not Provided
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Renal Transplantation
  • Heart Transplantation
Drug: Cyclosporine A
Not Provided
Loftheim H, Midtvedt K, Hartmann A, Reisæter 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
September 2006
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00139009
SUPER-CsA
Not Provided
Not Provided
Not Provided
Not Provided
University of Oslo School of Pharmacy
Not Provided
Study Director: Anders Åsberg, MSc University of Oslo
University of Oslo School of Pharmacy
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP