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 is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01596062
First received: September 29, 2011
Last updated: December 4, 2012
Last verified: December 2012
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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 |
| Estimated Primary Completion Date: | April 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: | December 4, 2012 |
| 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 May 19, 2013