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Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients

An Extension to a 12-month, Open-label, Randomised, Multicenter, Sequential Cohort, 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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00820911
Enrollment
175
Registered
2009-01-12
Start date
2008-09-30
Completion date
2012-07-31
Last updated
2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney transplant, AEB071

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.

Interventions

DRUGcyclosporine (reduced exposure) / everolimus

twice daily

DRUGAEB071 300 mg b.i.d. / everolimus

twice daily

DRUGAEB071 200 mg b.i.d. / everolimus

twice daily

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patient has been maintained on study drug for 12 months in the core study

Exclusion criteria

* Not applicable * Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frame
renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formulaat months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Secondary

MeasureTime frame
efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-upat months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Countries

Argentina, Australia, Austria, Belgium, Brazil, Colombia, Czechia, France, Germany, Italy, Netherlands, Norway, Singapore, Slovakia, Spain, Switzerland, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026