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

Stopped early · Phase 2

Conditions studied: Kidney Transplantation

In brief

This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.

Key facts

Study ID

NCT00555789

Run by

Novartis Pharmaceuticals

People needed

137

Starts

2007-10-01

Expected to finish

2008-03-01

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…

• Participation in core study CAEB071A2203
• The patient has been maintained on AEB071/mycophenolic acid or tacrolimus/mycophenolic acid, consistent with their original randomization, at their core study Month 12 visit.
• Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).

You may not qualify if…

• Pregnancy. Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Madison, Wisconsin, United States
• Novartis Investigative Site — Halifax, Canada
• Novartis Investigative Site — Le Kremlin-Bicêtre, France
• Novartis Investigative Site — Nantes, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Cologne, Germany
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Bologna, Italy
• Novartis Investigative Site — Florence, Italy
• Novartis Investigative Site — Padova, Italy
• Novartis Investigative Site — Llobregat, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Málaga, Spain
• Novartis Investigative Site — Valencia, Spain
• Novartis Investigative Site — Basel, Switzerland
• Novartis Investigative Site — Bern, Switzerland
• Novartis Investigative Site — Zurich, Switzerland
• Novartis Investigative Site — Cardiff, United Kingdom
• Novartis Investigative Site — Glasgow, United Kingdom

Full record on ClinicalTrials.gov

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