Prospective donor-specific Cellular alloresponse assessment for Immunosuppression Minimization in de novo renal transplantatio

Phase 2

Recruiting

• Conditions: immuneresponse; renal transplantation; 10038430

• Registration Number: NL-OMON45147
• Lead Sponsor: Charite Universiteitskliniek Berlijn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1) Men and women, age >=18 years.
2) Subject must be a recipient of a first renal transplant from a deceased or living donor.
3) Subject must have a current documented PRA <20% and no detectable anti-class I and II HLA antibodies by solid phase assay (Luminex®).
4) Subject is willing to provide signed written informed consent.

Exclusion Criteria

1) Subjects undergoing renal transplant with a current documented PRA >20% and/or detectable anti-class I and II HLA antibodies by solid phase assay (Luminex®).
2) CDC positive cross match.
3) Subjects receiving an allograft from a donor older than 65 years with elevated creatinine levels and/or treated diabetes.
4) Cold ischemia time (CIT) higher than 24h.
5) Subjects with a prior solid organ transplant (SOT), including renal re-transplantation, or receiving a concurrent SOT.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main objective of the study is to demonstrate the utility and safety<br /><br>of the IFN-&gamma; ELISPOT marker for the stratification of kidney transplant<br /><br>recipients into low and high IS regimens. The enrichment study will test<br /><br>non-inferiority of low IS regimen compared to high IS regimen,<br /><br>assuming 10% of BPAR at 6-months in the control group, and allowing a<br /><br>non-inferiority limit of maximum 15%.</p><br>