NCT04404127

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. 1.Primary outcomes:
  2. 2.Secondary outcomes:
  3. 3.Patient and graft survival at 1 year
  4. 4.Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months
  5. 5.Emergence of de novo donor specific antibodies (DSAs)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

2.7 years

First QC Date

May 19, 2020

Last Update Submit

February 16, 2021

Conditions

Kidney Transplantation

Keywords

basiliximabRejectionDe no vo donor specific antibodiesLow immunological riskInduction

Outcome Measures

Primary Outcomes (1)

  • Rate of biopsy proven acute rejection within first year following transplant

    1 year after transplant

Secondary Outcomes (3)

  • 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

Study Arms (2)

No induction Arm

PLACEBO COMPARATOR
Other: Normal Saline

Induction with basiliximab

ACTIVE COMPARATOR
Drug: Basiliximab 20 milligram [Simulect]

Interventions

Basiliximab 20 milligram [Simulect]DRUG

Basiliximab

Induction with basiliximab
Normal SalineOTHER

No-Induction

No induction Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Faisal Specialist Hospital and Research Centre (KFSHRC)

Riyadh, 11211, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology

Interventions

BasiliximabSaline Solution

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Aziza A. Ajlan, B.Sc. Pharm. BCPS. Clinical pharmacy specialist- Solid Organ Transplant

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 27, 2020

Study Start

September 1, 2020

Primary Completion

May 1, 2023

Study Completion

May 1, 2025

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)