Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation - Full Text View

Sponsors and Collaborators:	Hannover Medical School Hoffmann-La Roche
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00359658

Purpose

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	Intervention
Heart Transplantation	Drug: prednisolon withdrawal; Cyclosporin A; Mycophenolatmofetil

MedlinePlus related topics: Heart Transplantation

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Prednisone Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:

Renal function evaluated by serum creatinine at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cardiovascular risk factors at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]
Acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: Yes ]
Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	November 2004
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 withdrawal; Cyclosporin A; Mycophenolatmofetil 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 ng/ml

Arms

Assigned Interventions

1: Experimental

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 withdrawal; Cyclosporin A; Mycophenolatmofetil

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 ng/ml

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359658

Locations

Germany
Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Hannover, Germany, 30625

Sponsors and Collaborators

Hannover Medical School

Hoffmann-La Roche

Investigators

Study Director:

Christoph Bara, Dr. med.

Hannover Medical School, Department of Thoracic and Cardiovascular Surgery

More Information

Responsible Party:	Clinic for Cardiothoracic, Transplantation and Vascular Surgery, HannoverMS ( Dr. med. Chhristoph Bara )
Study ID Numbers:	KKS-94/2004
Study First Received:	August 1, 2006
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00359658
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:

Cyclosporine
Glucocorticoids
renal insufficiency, chronic
long-term care

Study placed in the following topic categories:

Prednisone
Renal Insufficiency
Cyclosporine
Methylprednisolone
Clotrimazole
Miconazole
Tioconazole

Methylprednisolone acetate
Prednisolone acetate
Cyclosporins
Renal Insufficiency, Chronic
Prednisolone
Mycophenolate mofetil
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Enzyme Inhibitors
Protective Agents

Neuroprotective Agents
Hormones
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Antifungal Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009