Phase 2
Completed N=16
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)
Renal Transplantation
Source: ClinicalTrials.gov NCT01596062 ↗
Enrolled (actual)
16
Serious AEs
56.3%
Results posted
Jul 2014
Primary outcomePrimary: Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84 — 8.4; 11.1; 9.7 Weeks * Percentage of saturated CD25
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84 |
8.4; 11.1; 9.7 | — |
| PRIMARY Saturation Rate of CD25 Antigen Saturation by Basiliximab |
0.0; 0.0; 0.0; 93.7; 96.7; 94.7 | — |
| SECONDARY AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84 |
7.0; 9.9; 8.4 | — |
| SECONDARY Percentage of T-cells That Bind Basiliximab to CD25 Receptors |
0.0; 0.0; 4.7; 95.3; 96.2; 81.6 | — |
| SECONDARY Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells |
0.5; 0.9; 0.7; 0.6; 1.1; 0.9 | — |
| SECONDARY Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) |
66.7; 83.3; 42.9; 33.3; 16.7; 57.1 | — |
| SECONDARY Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity |
66.7; 100.0; 85.7; 33.3; 0.0; 14.3 | — |
| SECONDARY Percentage of Participants With of Treatment Failures |
66.7; 66.7; 14.3; 33.3; 33.3; 85.7 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24 |
35.0; 53.8; 49.9; 31.9; 55.7; 54.4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01596062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.