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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00403416

Enrollment

215

Registered

2006-11-23

Start date

2006-10-31

Completion date

2008-05-31

Last updated

2020-12-17

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

Conditions

Kidney Transplantation

Keywords

AEB071, Tacrolimus, Mycophenolic acid, Basiliximab, Rejection, Kidney function, Immunosuppression

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.

Interventions

DRUGAEB071

DRUGMycophenolic Acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate)	at 6 months
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
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
Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms	from Month 3 to Month 6
Safety and tolerability	at 3, 6 and 12 months

Countries

Canada, France, Germany, Italy, Spain, Switzerland, United Kingdom, United States

Outcome results

None listed

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