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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04404127

Enrollment

140

Registered

2020-05-27

Start date

2020-09-01

Completion date

2025-05-31

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

basiliximab, Rejection, De no vo donor specific antibodies, Low immunological risk, Induction

Brief summary

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: 1. Primary outcomes: Biopsy proven acute rejection within first year following transplant 2. Secondary outcomes: 1. Patient and graft survival at 1 year 2. Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months 3. Emergence of de novo donor specific antibodies (DSAs)

Interventions

DRUGBasiliximab 20 milligram [Simulect]

Basiliximab

OTHERNormal Saline

No-Induction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

The trial will be blinded with respect to Basiliximab induction allocation. The study will be blinded to subjects and site study investigators, with the following exceptions: A single pharmacist A single biostatistician Patients with receive either basiliximab or an intravenous piggyback (IVPB) with normal saline depending on their allocation.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* • Male or female ≥ 18 years * Living donor * Low immunological risk (defined as): 1. First (primary) transplant 2. ≤ 4 antigen mismatches (HLA matching scheme) 3. 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

Design outcomes

Primary

Measure	Time frame
Rate of biopsy proven acute rejection within first year following transplant	1 year after transplant

Secondary

Measure	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

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026