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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04404127
• Other study ID #: RAC # 2191177
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: May 2025

Study information

• Verified date: February 2021
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 2025
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Basiliximab 20 milligram [Simulect]
Basiliximab

Other:
• Normal Saline
No-Induction

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital and Research Centre (KFSHRC)	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of biopsy proven acute rejection within first year following transplant		1 year after transplant
Secondary	Rate of graft survival at 1 year		1 year after transplant
Secondary	Rate of decline in eGFR at 6 months and at 12 months		1 year after transplant
Secondary	Rate of emergence of de novo donor specific antibodies (DSAs)		1 year after transplant