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Completed

NCT Number: NCT00359658

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

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.

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Key information

Conditions

Heart Transplantation Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannover Medical School, Department of Thoracic and Cardiovascular Surgery

Hanover, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prednisolon

Drug

prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal

Other names: Decortin, steroid withdrawal

Mycophenolatmofetile

Drug

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

cyclosporin A

Drug

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 names: Sandimmun optoral

Primary outcomes

  1. Renal function evaluated by serum creatinine at month 12 and month 24

    Time frame: month 12 and month 24

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Aug 2, 2006
Registry last updated
Feb 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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