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

King Faisal Specialist Hospital & Research Center

Status and phase: Enrolling; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Basiliximab 20 milligram [Simulect]; Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04404127

RAC # 2191177

Details and patient eligibility

About

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)

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

140 participants in 2 patient groups, including a placebo group

No induction Arm

Placebo Comparator group

Treatment:

Other: Normal Saline

Induction with basiliximab

Active Comparator group

Treatment:

Drug: Basiliximab 20 milligram [Simulect]