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)

Phase 2 Completed 16 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2012-03
Primary completion: 2013-03
Completion: 2013-03

Outcome

Met primary endpoint

paper P = 0.020 for basiliximab 80 mg + cyclosporine versus controls PMID 26369526 ↗

Publications

Thibault G, Paintaud G, Legendre C, Merville P, Coulon M, Chasseuil E, Ternant D, Rostaing L, Durrbach A, Di Giambattista F, Buchler M, Lebranchu Y. CD25 blockade in kidney transplant patients randomized to standard-dose or high-dose basiliximab with cyclosporine, or high-dose basiliximab in a calcineurin inhibitor-free regimen. Transpl Int. 2016 Feb;29(2):184-95. doi: 10.1111/tri.12688. Epub 2015 Oct 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Basiliximab	Monoclonal antibody	40 mg	—
Subject	Basiliximab	Monoclonal antibody	80 mg	—
Subject	Cyclosporine	Peptide	—	—
Subject	Everolimus	Small molecule	—	—
Background	mycophenolic acid	Small molecule	720 mg	Oral

Indications

No indication recorded.