Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation
NCT ID: NCT00359658
Last Updated: 2009-02-13
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2004-11-30
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
prednisolon
prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal
Mycophenolatmofetile
Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily
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
Interventions
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prednisolon
prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal
Mycophenolatmofetile
Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Hannover Medical School
OTHER
Responsible Party
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Clinic for Cardiothoracic, Transplantation and Vascular Surgery, HannoverMS
Principal Investigators
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Christoph Bara, Dr. med.
Role: STUDY_DIRECTOR
Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Locations
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Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Hanover, , Germany
Countries
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References
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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.
Other Identifiers
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KKS-94/2004
Identifier Type: -
Identifier Source: org_study_id
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