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Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation

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ClinicalTrials.gov Identifier: NCT00359658
Recruitment Status : Completed
First Posted : August 2, 2006
Last Update Posted : February 13, 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 first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an effective immunosuppressive agent, will minimize the risk of acute rejection episodes.

Condition or disease Intervention/treatment Phase
Heart Transplantation Drug: prednisolon 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. Calcineurin inhibitors are associated with chronic nephrotoxicity, while long-term administration of steroids results in an increased incidence of cardiovascular risk factors (e.g. hypertension, lipometabolic disorders, steroid induced diabetes, adipositas)and therefore, carries the potential of graft disfunction.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 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 Withdrawal of Steroids, Cyclosporine A Dose Reduction and a Switch to Mycophenolatmofetile for Patients After Heart Transplantation in the Long-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
prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal; Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily; Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 mg/ml
 Drug: prednisolon
prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal
Other Names:
  • Decortin
  • steroid withdrawal

Drug: Mycophenolatmofetile
Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily
Other Names:
  • MMF
  • Cellcept

Drug: Cyclosporin A
Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 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. Cardiovascular risk factors at month 12 and month 24 [ Time Frame: month 12 and month 24 ]
  2. Acute rejection episodes, gastrointestinal disorders and other adverse events 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 and corticosteroids for at least six 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): NCT00359658


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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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. med. Chhristoph Bara, Clinic for Cardiothoracic, Transplantation and Vascular Surgery, HannoverMS
ClinicalTrials.gov Identifier: NCT00359658    
Other Study ID Numbers: KKS-94/2004
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: February 2009
Keywords provided by Hannover Medical School:
Cyclosporine
Glucocorticoids
renal insufficiency, chronic
long-term care
Additional relevant MeSH terms:
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Cyclosporine
Prednisolone
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
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents