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Sponsored by: |
Novartis Pharmaceuticals |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00403416 |
This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.
Condition | Intervention | Phase |
---|---|---|
Kidney Transplantation |
Drug: AEB071 Drug: Mycophenolic Acid |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 12-Month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients |
Enrollment: | 215 |
Study Start Date: | October 2006 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Mycophenolic Acid / tacrolimus: Active Comparator | Drug: Mycophenolic Acid |
AEB071 / tacrolimus arm 1: Experimental | Drug: AEB071 |
AEB071 / tacrolimus arm 2: Experimental | Drug: AEB071 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143-0780 | |
United States, Ohio | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106-5048 | |
United States, Wisconsin | |
University of Wisconsin Hospital and Clinics | |
Madison, Wisconsin, United States, 53792-7375 | |
Canada | |
QE II Health Sciences Center | |
Halifax, Canada, B3H 1V7 | |
France | |
CHU de Rangueil | |
Toulouse, France, 31403 | |
Hopital Hotel Dieu | |
Nantes, France, 44035 | |
Hopital Necker | |
Paris, France, 75015 | |
Hopital Kremlin Bicetre | |
Le Kremlin Bicetre, France, 94270 | |
Germany | |
Universitaetsklinik Charite | |
Berlin, Germany, 10117 | |
Klinikum der Humboldt Universitat Charite | |
Berlin, Germany, 13353 | |
Medizinische Hochschule Hannover | |
Hannover, Germany, 30625 | |
Univ. - Klinikum Heidelberg | |
Heidelberg, Germany, 69120 | |
Staedt. Krankenhaus Koeln-Merheim | |
Koeln, Germany, 51109 | |
Universitaetsklinikum Essen | |
Essen, Germany, 45122 | |
Italy | |
Azienda Ospedaliera di Padova - Universita degli Studi | |
Padova, Italy, 35128 | |
Az. Osp. Di Bologna Polici. S. Orsola - Malpighi | |
Bologna, Italy, 40138 | |
Azienda Opedaliera Careggi - Universita degli Studi | |
Firenze, Italy, 50134 | |
Spain | |
Ciutat Santitaria I Univessitaria de Bellvitge | |
Hospitalet de Llobregat, Spain, 08907 | |
Hospital Doctor Peset | |
Valencia, Spain, 46017 | |
Complejo Hospitalario Carlos Haya | |
Malaga, Spain, 28041 | |
Hospital 12 de Octubre | |
Madrid, Spain, 28041 | |
Switzerland | |
Universitätsspital Zürich | |
Zürich, Switzerland, 8091 | |
Inselspital Bern | |
Bern, Switzerland, 3010 | |
Universitatsspital Basel | |
Basel, Switzerland, 4031 | |
United Kingdom | |
University Hospital of Wales | |
Cardiff, United Kingdom, CF14 4XW | |
Manchester Royal Infirmary | |
Manchester, United Kingdom | |
Saint George's University of London | |
London, United Kingdom | |
Western Infirmary | |
Glasgow, United Kingdom, G11 6NT |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CAEB071A2203 |
Study First Received: | November 22, 2006 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00403416 History of Changes |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Italy: Ministry of Health; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Canada: Health Canada; Switzerland: Swissmedic |
AEB071 Tacrolimus Mycophenolic acid Basiliximab |
Rejection Kidney function Immunosuppression |
Anti-Bacterial Agents Basiliximab Immunologic Factors |
Mycophenolic Acid Tacrolimus Immunosuppressive Agents |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Mycophenolic Acid |
Enzyme Inhibitors Tacrolimus Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |