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
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: AEB071
Drug: mycophenolic plus tacrolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 137
Study Start Date: October 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
mycophenolic and tacrolimus
Drug: mycophenolic plus tacrolimus
720mg b.i.d. 2yrs
Experimental: 2
mycophenolic and tacrolimus
Drug: AEB071
200mg oral b.i.d.
Other Name: mycophenolic plus tacrolimus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555789

Locations
United States, California
Novartis Investigative Site
San Francisco, California, United States, 94143-0780
United States, Wisconsin
Novartis Investigative Site
Madison, Wisconsin, United States, 53706
Canada
Novartis Investigative Site
Halifax, Canada, B3H 1V7
France
Novartis Investigative Site
Le Kremlin Bicetre, France, 94270
Novartis Investigative Site
Nantes, France, 44035
Novartis Investigative Site
Paris, France, 75015
Novartis Investigative Site
Toulouse, France, 31403
Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Koeln, Germany
Italy
Novartis Investigative Site
Bologna, Italy, 40138
Novartis Investigative Site
Firenze, Italy, 50134
Novartis Investigative Site
Padova, Italy, 35128
Spain
Novartis Investigative Site
Llobregat, Spain, 08907
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Malaga, Spain, 28041
Novartis Investigative Site
Valencia, Spain, 46017
Switzerland
Novartis Investigative Site
Basel, Switzerland, 4031
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Zürich, Switzerland, 8091
United Kingdom
Novartis Investigative Site
Cardiff, United Kingdom, CF14 4XW
Novartis Investigative Site
Glasgow, United Kingdom, G11 6NT
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Manchester, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00555789     History of Changes
Other Study ID Numbers: AEB071A2203E1
Study First Received: November 8, 2007
Last Updated: July 31, 2012
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
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic

Keywords provided by Novartis:
kidney transplantation
rejection
AEB071
tacrolimus
mycophenolic acid
immunosuppression

Additional relevant MeSH terms:
Tacrolimus
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014