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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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00555789
Collaborator
(none)
137
Enrollment
27
Locations
2
Arms
5
Duration (Months)
5.1
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
137 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • mycophenolic plus tacrolimus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site San Francisco California United States 94143-0780
    2 Novartis Investigative Site Madison Wisconsin United States 53706
    3 Novartis Investigative Site Halifax Canada B3H 1V7
    4 Novartis Investigative Site Le Kremlin Bicetre France 94270
    5 Novartis Investigative Site Nantes France 44035
    6 Novartis Investigative Site Paris France 75015
    7 Novartis Investigative Site Toulouse France 31403
    8 Novartis Investigative Site Berlin Germany 13353
    9 Novartis Investigative Site Berlin Germany
    10 Novartis Investigative Site Essen Germany 45122
    11 Novartis Investigative Site Hannover Germany 30625
    12 Novartis Investigative Site Heidelberg Germany 69120
    13 Novartis Investigative Site Koeln Germany
    14 Novartis Investigative Site Bologna Italy 40138
    15 Novartis Investigative Site Firenze Italy 50134
    16 Novartis Investigative Site Padova Italy 35128
    17 Novartis Investigative Site Llobregat Spain 08907
    18 Novartis Investigative Site Madrid Spain 28041
    19 Novartis Investigative Site Malaga Spain 28041
    20 Novartis Investigative Site Valencia Spain 46017
    21 Novartis Investigative Site Basel Switzerland 4031
    22 Novartis Investigative Site Bern Switzerland 3010
    23 Novartis Investigative Site Zürich Switzerland 8091
    24 Novartis Investigative Site Cardiff United Kingdom CF14 4XW
    25 Novartis Investigative Site Glasgow United Kingdom G11 6NT
    26 Novartis Investigative Site London United Kingdom
    27 Novartis Investigative Site Manchester United Kingdom

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis, Novartis

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00555789
    Other Study ID Numbers:
    • AEB071A2203E1
    First Posted:
    Nov 9, 2007
    Last Update Posted:
    Dec 17, 2020
    Last Verified:
    Jul 1, 2012
    Keywords provided by Novartis Pharmaceuticals
    kidney transplantation
    rejection
    AEB071
    tacrolimus
    mycophenolic acid
    immunosuppression
    Additional relevant MeSH terms:
    Tacrolimus

    Study Results

    No Results Posted as of Dec 17, 2020