Clinical trial NCT00359658: Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Transplantation
Keywords: Cyclosporine
Glucocorticoids
renal insufficiency, chronic
long-term care
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2006-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Renal function evaluated by serum creatinine at month 12 and month 24
timeFrame: month 12 and month 24
Secondary outcomes:
measure: Cardiovascular risk factors at month 12 and month 24
timeFrame: month 12 and month 24
measure: Acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24
timeFrame: month 12 and month 24
measure: Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24
timeFrame: month 12 and month 24
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Study officials:
affiliation: Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
name: Christoph Bara, Dr. med.
role: STUDY_DIRECTOR
References:
citation: Faulhaber M, Mading I, Malehsa D, Raggi MC, Haverich A, Bara CL. Steroid withdrawal and reduction of cyclosporine A under mycophenolate mofetil after heart transplantation. Int Immunopharmacol. 2013 Apr;15(4):712-7. doi: 10.1016/j.intimp.2013.02.012. Epub 2013 Feb 28.