Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients

Completed · Phase 1/Phase 2

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT00403416

Run by

Novartis Pharmaceuticals

People needed

215

Starts

2006-10-01

Expected to finish

2008-05-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients of any race 18 years or older
• Adult recipients of a kidney transplant from a deceased or from a living donor
• Recipients of a functioning Kidney:. Graft must be functional no later than 36h after transplantation.

You may not qualify if…

• Need for medication prohibited by the protocol
• Patients or donors infected with hepatitis B or C, or with HIV.
• Patients with a history of cancer
• Patients with severe systemic infections Patients with heart diseases (own or family history) which are associated with an increased risk for arrhythmias.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• QE II Health Sciences Center — Halifax, Canada
• Hopital Kremlin Bicetre — Le Kremlin-Bicêtre, France
• Hopital Hotel Dieu — Nantes, France
• Hopital Necker — Paris, France
• CHU de Rangueil — Toulouse, France
• Universitaetsklinik Charite — Berlin, Germany
• Klinikum der Humboldt Universitat Charite — Berlin, Germany
• Staedt. Krankenhaus Koeln-Merheim — Cologne, Germany
• Universitaetsklinikum Essen — Essen, Germany
• Medizinische Hochschule Hannover — Hanover, Germany
• Univ. - Klinikum Heidelberg — Heidelberg, Germany
• Az. Osp. Di Bologna Polici. S. Orsola - Malpighi — Bologna, Italy
• Azienda Opedaliera Careggi - Universita degli Studi — Florence, Italy
• Azienda Ospedaliera di Padova - Universita degli Studi — Padova, Italy
• Ciutat Santitaria I Univessitaria de Bellvitge — L'Hospitalet de Llobregat, Spain
• Hospital 12 de Octubre — Madrid, Spain
• Complejo Hospitalario Carlos Haya — Málaga, Spain
• Hospital Doctor Peset — Valencia, Spain
• Universitatsspital Basel — Basel, Switzerland
• Inselspital Bern — Bern, Switzerland
• Universitätsspital Zürich — Zurich, Switzerland
• University Hospital of Wales — Cardiff, United Kingdom

Full record on ClinicalTrials.gov

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