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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01596062
First received: September 29, 2011
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Renal Transplantation
Drug: Basiliximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Randomized, Open-label, Phase 2, Lasting 12 Weeks, Evaluating the Pharmacodynamics, Efficacy and Safety of Basiliximab in Adult Patients With de Novo Renal Transplant Patients at Low Risk Receiving Either a Cumulative Dose Basiliximab 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Area under the curve (AUC) of CD25 antigen saturation by basiliximab [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    Percentage of T cells expressing CD25 will be calculated at predetermined time (predose, D1, D4, D21, D28, D42, D56, D84 post first dose) using an antibody directed against the epitope binding of basiliximab. Of these evaluations saturation kinetics including AUC of saturation will be measured.


Secondary Outcome Measures:
  • Basiliximab binding to CD25 receptors [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    Percentage of binding

  • Expression of CD25 receptors on T lymphocytes [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    Percentage of CD25 receptors

  • Lymphocyte sub-population counts [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    Percentage of Lymphocyte sub-populations

  • Describe blood kinetics parameters of basiliximab [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    Kinetics parameters, PK/PD models

  • Incidence of treatment failure (BPAR, graft loss, death, loss to follow-up). [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    Incidence of treatment failure (BPAR, graft loss, death, loss to follow-up).

  • Change from baseline in renal function measured by estimated glomerular filtration rate. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Evolution of eGFR

  • Assessment of safety through the number of patients with Adverse Events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Adverse events (AEs).


Enrollment: 16
Study Start Date: March 2012
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
20 mg IV on transplant day (D0) and day 4 post-transplantation
Drug: Basiliximab
20 mg IV on transplant day (D0) and day 4 post-transplantation
Other Name: Simulect®
Experimental: Arm 2
40 mg IV on transplant day (D0) and day 4 post-transplantation
Drug: Basiliximab
40 mg IV on transplant day (D0) and day 4 post-transplantation
Other Name: Simulect®
Experimental: Arm 3
40 mg IV on transplant day (D0) and day 4 post-transplantation
Drug: Basiliximab
40 mg IV on transplant day (D0) and day 4 post-transplantation
Other Name: Simulect®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Male or female patients, aged between 18 and 65 years.
  • 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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596062

Locations
France
Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Kremlin-Bicêtre, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Tours, France
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01596062     History of Changes
Obsolete Identifiers: NCT01469390
Other Study ID Numbers: CCHI621AFR05, 2010-024231-16
Study First Received: September 29, 2011
Last Updated: September 5, 2013
Health Authority: France: L'Agence nationale de sécurité du médicament et des produits de santé (ANSM)

Keywords provided by Novartis:
Basiliximab
renal transplantation
CNI-free
everolimus

Additional relevant MeSH terms:
Everolimus
Basiliximab
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014