Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study)

Novartis

Status and phase: Completed; Phase 2

Conditions: Renal Transplantation

Treatments: Drug: Corticosteroids; Drug: Myfortic®; Drug: Simulect®; Drug: Certican®; Drug: Neoral®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01596062

2010-024231-16 (EudraCT Number)

CCHI621AFR05

Details and patient eligibility

About

The aims of this study are to extensively study the levels of CD25-Receptors saturation and expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to demonstrate that saturation and expression vary according to the dose of Simulect® given), and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the data with Neoral®.

It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin inhibitor free immunosuppressant therapy.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients receiving a primary renal graft from a deceased or living, related or unrelated donor and who require basiliximab induction therapy
• Cold ischemia time < 30 hours

Exclusion (Non inclusion) criteria:

• Patients undergoing multi-organ transplantation, including both kidneys, or who have previously undergone organ transplantation, including renal transplantation
• Patients receiving a graft from a non-heart-beating donor
• A-B-O incompatible graft or positive T cell crossmatch
• Patients receiving a graft from an expanded criteria donor according to the UNOS definition (donor older than 60 years or donor aged between 50 and 60 years and presence of at least 2 of the following factors: hypertension, serum creatinine concentration ≥ 132 µmol/mL, cardiovascular cause of death)
• Positive anti-HLA antibodies (Luminex) prior to transplantation
• Patients whose original renal disease was primary focal and segmental hyalinosis or was related to atypical hemolytic uremic syndrome
• EBV-negative patients receiving a graft from an EBV-positive donor (EBV D+R-)

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Simulect 40mg + Neoral + Myfortic + steroids

Active Comparator group

Description:

A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids

Treatment:

Drug: Neoral®

Drug: Corticosteroids

Drug: Simulect®

Drug: Myfortic®

Simulect 80mg + Neoral + Myfortic + steroids

Experimental group

Description:

A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids

Treatment:

Drug: Neoral®

Drug: Corticosteroids

Drug: Simulect®

Drug: Myfortic®

Simulect 80mg + Certican + Myfortic + steroids

Experimental group

Description:

A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids

Treatment:

Drug: Certican®

Drug: Corticosteroids

Drug: Simulect®

Drug: Myfortic®