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

NCT04404127 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-02-18

No results posted yet for this study

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)

Conditions

  • Kidney Transplantation

Interventions

DRUG

Basiliximab 20 milligram [Simulect]

Basiliximab

OTHER

Normal Saline

No-Induction

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-05-31
Completion
2025-05-31
FDA Drug
Yes

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04404127 on ClinicalTrials.gov