Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients

Study Overview
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Brief Summary
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Background: Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated Aims: To compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol (Appendix 2) Methods: Prospective, randomized, double blind, non-inferiority, controlled clinical trial Expected Outcomes: Primary outcomes: Biopsy proven acute rejection within first year following transplant Secondary outcomes: Patient and graft survival at 1 year Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months Emergence of de novo donor specific antibodies (DSAs)

Official Title
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Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Basiliximab 20 milligram [Simulect]
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Male or female ≥ 18 years Living donor Low immunological risk (defined as): First (primary) transplant ≤ 4 antigen mismatches (HLA matching scheme) Negative HLA Ab screening Exclusion Criteria: • High immunological risk HLA identical or zero mismatched transplants Receiving cyclosporin as primary maintenance immunosuppressant Human immunodeficiency virus (HIV) co-infection Pregnant or nursing female Has received an investigational medication within the past 30 days Has a known contraindication to the administration of Basiliximab Suspected or known to have a serious infection Multi-organ transplant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No induction Arm<br> | Other: Normal Saline<br>* No-Induction<br>|
| Active Comparator: Induction with basiliximab<br> | Drug: Basiliximab 20 milligram [Simulect]<br>* Basiliximab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of biopsy proven acute rejection within first year following transplant |  | 1 year after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of graft survival at 1 year |  | 1 year after transplant | 
| Rate of decline in eGFR at 6 months and at 12 months |  | 1 year after transplant | 
| Rate of emergence of de novo donor specific antibodies (DSAs) |  | 1 year after transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basiliximab, Rejection, De no vo donor specific antibodies, Low immunological risk, Induction