Clinical trial NCT01596062: 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)
Official title: Prospective, Multicenter, Randomized, Open-label, Phase 2, Lasting 12 Weeks, Evaluating the Pharmacodynamics, Efficacy and Safety of Basiliximab in de Novo Adult Renal Transplant Patients at Low Risk Receiving Either a Cumulative Dose of Basiliximab of 40 or 80 mg in Combination With Cyclosporine Microemulsion, or a Cumulative Dose of 80 mg of Basiliximab Without Calcineurin Inhibitor, With Additional Follow-up of 12 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Transplantation
Keywords: Basiliximab
renal transplantation
CNI-free
everolimus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84
timeFrame: Day 84 (Week 12) after transplantation
measure: Saturation Rate of CD25 Antigen Saturation by Basiliximab
timeFrame: Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation
Secondary outcomes:
measure: AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84
timeFrame: Day 84 (Week 12) post-transplantation
measure: Percentage of T-cells That Bind Basiliximab to CD25 Receptors
timeFrame: Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation
measure: Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
timeFrame: Day 0, Day 6, Day 42, Day 84 (Week 12)
measure: Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR)
timeFrame: Day 84 (Week 12), Week 24 post-transplantation
measure: Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
timeFrame: Day 84 (Week 12), Week 24 post-transplantation
measure: Percentage of Participants With of Treatment Failures
timeFrame: Day 84 (Week 12), Week 24
measure: Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24
timeFrame: Day 8, Week 24
Other outcomes:
Locations:
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Paris cedex 15
country: France
facility: Novartis Investigative Site
city: Tours Cedex
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceticals
role: STUDY_DIRECTOR
References:
citation: 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.