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Sponsored by: |
University Medical Center Goettingen |
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Information provided by: | University Medical Center Goettingen |
ClinicalTrials.gov Identifier: | NCT00890253 |
A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti-body (basiliximab), mycophenolic acid (MPA), and mammalian target of rapamycin (mTOR) - inhibition with everolimus to determine its safety and to investigate the preliminary efficacy in patients with impaired renal function at the time-point of liver transplantation (OLT) with regards to the incidence of steroid resistant acute rejection within the first 30 days after liver transplantation.
Condition | Intervention | Phase |
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Liver Transplantation Chronic Renal Insufficiency |
Drug: Basiliximab (Simulect) Drug: Myfortic Drug: everolimus (Certican) Drug: Prednisolone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Therapeutic Exploratory Study to Determine the Efficacy and Safety of Calcineurin-Inhibitor-Free de-Novo Immunosuppression After Liver Transplantation |
Estimated Enrollment: | 29 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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CNI-free Immunosuppression: Experimental
Immunosuppression after OLT including basiliximab, enteric-coated mycophenolate sodium (EC-MPS), and everolimus.
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Drug: Basiliximab (Simulect)
20 mg basiliximab (Simulect) iv on day 0 and 4 after OLT
Drug: Myfortic
1080 mg q12 EC-MPS (Myfortic) po starting within 24h after OLT
Drug: everolimus (Certican)
1 mg q12 everolimus (Certican) po starting on 10th post-operative day
Drug: Prednisolone
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
University Medical Center Goettingen | |
Goettingen, Germany, 37099 |
Study Director: | Aiman Obed, PD Dr. | University Medical Center Goettingen |
Principal Investigator: | Armin D Goralczyk, Dr. | University Medical Center Goettingen |
Responsible Party: | University Medical Center Goettingen ( PD Dr. Aiman Obed ) |
Study ID Numbers: | CILT08 |
Study First Received: | April 28, 2009 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00890253 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Renal impairment Liver transplantation Chronic Renal Insufficiency |
Anti-Inflammatory Agents Renal Insufficiency Immunologic Factors Methylprednisolone Hormone Antagonists Mycophenolic Acid Hormones, Hormone Substitutes, and Hormone Antagonists Prednisolone acetate Hormones Antibodies, Monoclonal Anti-Bacterial Agents Urologic Diseases Mycophenolate mofetil |
Kidney Diseases Methylprednisolone Hemisuccinate Immunoglobulins Everolimus Antineoplastic Agents, Hormonal Methylprednisolone acetate Glucocorticoids Immunosuppressive Agents Basiliximab Antibodies Renal Insufficiency, Chronic Prednisolone |
Everolimus Anti-Inflammatory Agents Renal Insufficiency Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Mycophenolic Acid Enzyme Inhibitors Antibiotics, Antineoplastic |
Immunosuppressive Agents Hormones Glucocorticoids Pharmacologic Actions Antibodies, Monoclonal Basiliximab Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Prednisolone Kidney Diseases |