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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00403416
Collaborator
(none)
215
Enrollment
28
Locations
3
Arms
19
Duration (Months)
7.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
215 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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, 2006
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
May 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Mycophenolic Acid / tacrolimus

Drug: Mycophenolic Acid
Experimental: AEB071 / tacrolimus arm 1

Drug: AEB071
Experimental: AEB071 / tacrolimus arm 2

Drug: AEB071

Outcome Measures

Primary Outcome Measures

  1. Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up [at 6 months]

Secondary Outcome Measures

  1. Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate) [at 6 months]

  2. Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up [at 3 and 12 months]

  3. Various efficacy endpoints, using treated BPAR, treated acute rejection (AR), death, graft loss, loss to follow-up and combinations thereof. [at Month 3, 6 and 12]

  4. Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms [from Month 3 to Month 6]

  5. Safety and tolerability [at 3, 6 and 12 months]

Eligibility Criteria

Criteria

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

Inclusion criteria

  • Male and female patients of any race 18 years or older

  • Adult recipients of a kidney transplant from a deceased or from a living donor

  • Recipients of a functioning Kidney:. Graft must be functional no later than 36h after transplantation.

Exclusion criteria

  • Need for medication prohibited by the protocol

  • Patients or donors infected with hepatitis B or C, or with HIV.

  • Patients with a history of cancer

  • Patients with severe systemic infections Patients with heart diseases (own or family history) which are associated with an increased risk for arrhythmias.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94143-0780
2 University Hospitals of Cleveland Cleveland Ohio United States 44106-5048
3 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792-7375
4 QE II Health Sciences Center Halifax Canada B3H 1V7
5 Hopital Kremlin Bicetre Le Kremlin Bicetre France 94270
6 Hopital Hotel Dieu Nantes France 44035
7 Hopital Necker Paris France 75015
8 CHU de Rangueil Toulouse France 31403
9 Universitaetsklinik Charite Berlin Germany 10117
10 Klinikum der Humboldt Universitat Charite Berlin Germany 13353
11 Universitaetsklinikum Essen Essen Germany 45122
12 Medizinische Hochschule Hannover Hannover Germany 30625
13 Univ. - Klinikum Heidelberg Heidelberg Germany 69120
14 Staedt. Krankenhaus Koeln-Merheim Koeln Germany 51109
15 Az. Osp. Di Bologna Polici. S. Orsola - Malpighi Bologna Italy 40138
16 Azienda Opedaliera Careggi - Universita degli Studi Firenze Italy 50134
17 Azienda Ospedaliera di Padova - Universita degli Studi Padova Italy 35128
18 Ciutat Santitaria I Univessitaria de Bellvitge Hospitalet de Llobregat Spain 08907
19 Hospital 12 de Octubre Madrid Spain 28041
20 Complejo Hospitalario Carlos Haya Malaga Spain 28041
21 Hospital Doctor Peset Valencia Spain 46017
22 Universitatsspital Basel Basel Switzerland 4031
23 Inselspital Bern Bern Switzerland 3010
24 Universitätsspital Zürich Zürich Switzerland 8091
25 University Hospital of Wales Cardiff United Kingdom CF14 4XW
26 Western Infirmary Glasgow United Kingdom G11 6NT
27 Saint George's University of London London United Kingdom
28 Manchester Royal Infirmary Manchester United Kingdom

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00403416
Other Study ID Numbers:
  • CAEB071A2203
First Posted:
Nov 23, 2006
Last Update Posted:
Dec 17, 2020
Last Verified:
May 1, 2017
Keywords provided by Novartis Pharmaceuticals
AEB071
Tacrolimus
Mycophenolic acid
Basiliximab
Rejection
Kidney function
Immunosuppression
Additional relevant MeSH terms:
Mycophenolic Acid

Study Results

No Results Posted as of Dec 17, 2020