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Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00359814
First received: August 1, 2006
Last updated: February 13, 2009
Last verified: February 2009

August 1, 2006
February 13, 2009
November 2004
June 2008   (final data collection date for primary outcome measure)
Renal function evaluated by serum creatinine at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]
renal function evaluated by serum creatinine at month 12 and month 24
Complete list of historical versions of study NCT00359814 on ClinicalTrials.gov Archive Site
  • acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: Yes ]
  • Cardiovascular risk factors at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]
  • Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]
  • acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24
  • cardiovascular risk factors at month 12 and month 24
  • quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24
Not Provided
Not Provided
 
Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation
Conversion Study to Optimize Immunosuppressive Regimen by Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction for Patients After Heart Transplantation in Lon-Term

The purpose of this study is to improve or save renal function by optimizing the immunosuppressive regimen by reducing the Cyclosporine A dose and the exchange of Azathioprine by Mycophenolatmofetile, which is an effective immunosuppressive agent and will minimize the risk of acute rejection episodes.

The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects.Long-term administration of calcineurin inhibitors is associated with chronic nephrotoxicity.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Transplantation
  • Drug: Mycophenolatmofetile
    Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily
    Other Names:
    • MMF
    • CellCept
  • Drug: Cyclosporin A
    Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml
    Other Name: Sandimmun optoral
Experimental: 1
Azathioprine administration: was stopped at day 0; Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily; Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml
Interventions:
  • Drug: Mycophenolatmofetile
  • Drug: Cyclosporin A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current immunosuppressive regimen: Cyclosporine A, Azathioprine and corticosteroids for at least 12 month
  • Heart transplantation above 3 years dated back
  • Serum creatinine < 3,5 mg/dl (310 µmol/l) and BUN < 150 mg/dl
  • Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month

Exclusion Criteria:

  • Carcinoma within the last 3 years
  • Acute rejection episodes during the last 6 month
  • Infection requiring therapeutic intervention
  • Hepatitis B, Hepatitis C or HIV infection
  • WBC < 3000/µl, haemoglobin < 9g/dl, platelets < 70.000/µl
  • Florid gastrointestinal ulcer
  • Haemodialysis within the last 4 weeks before study entry
  • Pregnancy / lactation
  • Administration of other immunosuppressive agents than prescribed
  • Mycophenolatmofetile incompatibility
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00359814
KKS-95/2004
No
Dr. med. Christoph Bara, Clinic for Cardiothoracic, Transplantation and Vascular Surgery, HannoverMS
Hannover Medical School
Hoffmann-La Roche
Study Director: Christoph Bara, Dr. med. Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Hannover Medical School
February 2009

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