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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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00555789
First received: November 8, 2007
Last updated: July 31, 2012
Last verified: July 2012
History of Changes

November 8, 2007
July 31, 2012
October 2007
March 2008   (final data collection date for primary outcome measure)
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. [ Time Frame: three Yrs ] [ Designated as safety issue: Yes ]
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. [ Time Frame: three Yrs ]
Complete list of historical versions of study NCT00555789 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Three yrs ] [ Designated as safety issue: No ]
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. [ Time Frame: Three yrs ]
Not Provided
Not Provided
 
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
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

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: AEB071
    200mg oral b.i.d.
    Other Name: mycophenolic plus tacrolimus
  • Drug: mycophenolic plus tacrolimus
    720mg b.i.d. 2yrs
  • Active Comparator: 1
    mycophenolic and tacrolimus
    Intervention: Drug: mycophenolic plus tacrolimus
  • Experimental: 2
    mycophenolic and tacrolimus
    Intervention: Drug: AEB071
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
137
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany,   Italy,   Spain,   Switzerland,   United Kingdom
 
NCT00555789
AEB071A2203E1
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP