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NCT00555789 Clinical Trial

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

Kidney Transplantation Clinical Trial

Official title:
A 24 Month Extension to a 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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00555789
Other study ID # AEB071A2203E1
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 2007
Est. completion date March 2008

Study information
Verified date July 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 137
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - 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). Exclusion criteria: - Pregnancy. Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AEB071
200mg oral b.i.d.
• mycophenolic plus tacrolimus
720mg b.i.d. 2yrs

Locations
Country Name City State
Canada Novartis Investigative Site Halifax
France Novartis Investigative Site Le Kremlin Bicetre
France Novartis Investigative Site Nantes
France Novartis Investigative Site Paris
France Novartis Investigative Site Toulouse
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Koeln
Italy Novartis Investigative Site Bologna
Italy Novartis Investigative Site Firenze
Italy Novartis Investigative Site Padova
Spain Novartis Investigative Site Llobregat
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Malaga
Spain Novartis Investigative Site Valencia
Switzerland Novartis Investigative Site Basel
Switzerland Novartis Investigative Site Bern
Switzerland Novartis Investigative Site Zürich
United Kingdom Novartis Investigative Site Cardiff
United Kingdom Novartis Investigative Site Glasgow
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Manchester
United States Novartis Investigative Site Madison Wisconsin
United States Novartis Investigative Site San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long term safety assessed by and renal safety defined by measuring renal function using Modification of Diet in Renal Disease (MDRD) formula for Glomerular Filtration Rate (GFR) beyond 12 months. three Yrs
Secondary Efficacy assessed by: the incidence over 36 months of the composite endpoint of biopsy proven rejection = 1A, graft loss, death, or loss to follow-up in the two study arms. Three yrs
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