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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Transplantation Drug: Mycophenolatmofetile Drug: Cyclosporin A Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2004
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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Arms and Interventions
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Arm Intervention/treatment
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Renal function evaluated by serum creatinine at month 12 and month 24 [ Time Frame: month 12 and month 24 ]

Secondary Outcome Measures :
  1. acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24 [ Time Frame: month 12 and month 24 ]
  2. Cardiovascular risk factors at month 12 and month 24 [ Time Frame: month 12 and month 24 ]
  3. Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24 [ Time Frame: month 12 and month 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359814


Locations
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Germany
Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Hoffmann-La Roche
Investigators
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Study Director: Christoph Bara, Dr. med. Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
More Information
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Responsible Party: Dr. med. Christoph Bara, Clinic for Cardiothoracic, Transplantation and Vascular Surgery, HannoverMS
ClinicalTrials.gov Identifier: NCT00359814    
Other Study ID Numbers: KKS-95/2004
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009
Keywords provided by Hannover Medical School:
Cyclosporine
renal insufficiency, chronic
long-term care
Additional relevant MeSH terms:
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Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors