Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation

A 12-month Open-label, Randomized, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00492869

Enrollment

124

Registered

2007-06-27

Start date

2007-01-31

Completion date

Unknown

Last updated

2020-12-22

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

Conditions

Kidney Transplantation

Keywords

kidney transplantation, rejection, AEB071, tacrolimus, mycophenolic, basiliximab, immunosuppression

Brief summary

Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.

Interventions

DRUGAEB071

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

Inclusion: * Male and female patients of any race 18 years or older * Adult recipients of kidney transplant from a deceased or living donor * Recipients of a functioning kidney within 24 hours post transplant Exclusion: * Need for medication prohibited by the protocol * Patients or donors infected with Hepatitis B,C or HIV * Patients with a history of cancer within last 5 years * Patients with history of significant cardiac disorder * Patients of high-risk immunological status Other protocol-defined inclusion/

Exclusion criteria

may apply.

Design outcomes

Primary

Measure	Time frame
Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms	—

Secondary

Measure	Time frame
Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies	—

Countries

Belgium, Canada, Germany, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

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