Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00504543
• Collaborator: (none)
• Enrollment: 311
• Locations: 26
• Arms: 3
• Duration (Months): 45
• Patients Per Site: 12
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: AEB071; Drug: Certican; Drug: Neoral	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 311 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 12 Month Open-label, Randomized, Multicenter, Sequential Cohort-group, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients.
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Neoral	Drug: Neoral; twice daily
Active Comparator: AEB071 high dose with Cetican reduced dose	Drug: AEB071; oral, twice daily; Drug: Certican; twice daily
Active Comparator: AEB071 low dose with Cetican standard dose	Drug: AEB071; oral, twice daily; Drug: Certican; twice daily

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, 3 months after transplantation. [12 months]

Secondary Outcome Measures

1. Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at Month 6; renal function at Month 3, Month 6 and Month 12 post transplant using GFR; PK [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 18 years or older

• Recipients of first kidney transplant from a deceased or living not related donor

Exclusion criteria

• Need for medication prohibited in the study

• Patients with heart disease (own or family history)

• Patients or donor HIV, Hepatitis B (HBsAg) or Hepatitis C (HCV) positive

• Patients with high immunological risks

• Patients with a history of cancer

• Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Argentina	Buenos Aires		Argentina	1107
2	Novartis Investigative Site	Buenos Aires		Argentina	1425
3	Australia	Sydney		Australia	2050
4	Australia	Sydney		Australia	5011
5	Austria	Innsbruck		Austria	6020
6	Austria	Wein		Austria	1090
7	Belgium	Gent		Belgium	9000
8	Brazil	Sao Paulo		Brazil	04038-002
9	Novartis Investigative Site	Bogota		Colombia
10	Novartis Investigative Site	Cali		Colombia
11	Czech Republic	Praha		Czech Republic	14021
12	France	Lille Cedex		France	59037
13	France	Toulouse		France	31055
14	Novartis Investigative Site	Berlin		Germany	10117
15	Novartis Investigative Site	Heidelberg		Germany	69120
16	Italy	Milano		Italy	20100
17	Italy	Milano		Italy	20122
18	Netherlands	Rotterdam		Netherlands	3000CA
19	Norway	Oslo		Norway	0027
20	Novartis Investigative Site	Singapore		Singapore	119074
21	Novartis Investigative Site	Banska Bystrica		Slovakia	97517
22	Novartis Investigative Site	Kosice		Slovakia	04066
23	Spain	Barcelona		Spain	08024
24	Spain	Madrid		Spain	28034
25	Novartis Investigative Site	Zurich		Switzerland	8091
26	Novartis Investigative Site	Taipie		Taiwan	10002

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00504543
• Other Study ID Numbers: CAEB071A2206
• First Posted: Jul 20, 2007
• Last Update Posted: Nov 18, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Novartis Pharmaceuticals: Kidney transplant, AEB071
• Additional relevant MeSH terms: Everolimus

Study Results

No Results Posted as of Nov 18, 2016