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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: AEB071; Drug: mycophenolic plus tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00555789

AEB071A2203E1

Details and patient eligibility

About

This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in core study CAEB071A2203
• The patient has been maintained on AEB071/mycophenolic acid or tacrolimus/mycophenolic acid, consistent with their original randomization, at their core study Month 12 visit.
• Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).

Exclusion criteria

• Pregnancy. Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

1

Active Comparator group

Description:

mycophenolic and tacrolimus

Treatment:

Drug: mycophenolic plus tacrolimus

2

Experimental group

Description:

mycophenolic and tacrolimus

Treatment:

Drug: AEB071