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Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart 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: NCT00359814
Recruitment Status : Completed
First Posted : August 2, 2006
Last Update Posted : February 16, 2009
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Hannover Medical School

Tracking Information
First Submitted Date  ICMJE August 1, 2006
First Posted Date  ICMJE August 2, 2006
Last Update Posted Date February 16, 2009
Study Start Date  ICMJE November 2004
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2008)
Renal function evaluated by serum creatinine at month 12 and month 24 [ Time Frame: month 12 and month 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2006)
Renal function evaluated by serum creatinine at month 12 and month 24
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2008)
  • acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24 [ Time Frame: month 12 and month 24 ]
  • Cardiovascular risk factors at month 12 and month 24 [ Time Frame: month 12 and month 24 ]
  • Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24 [ Time Frame: month 12 and month 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Transplantation
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2006)
23
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00359814
Other Study ID Numbers  ICMJE KKS-95/2004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. med. Christoph Bara, Clinic for Cardiothoracic, Transplantation and Vascular Surgery, HannoverMS
Study Sponsor  ICMJE Hannover Medical School
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Study Director: Christoph Bara, Dr. med. Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
PRS Account Hannover Medical School
Verification Date February 2009

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