An integrated immunological-pharmacological approach to improve long-term allograft functio

• Conditions: graft failure; kidney transplantation; 10029149

• Registration Number: NL-OMON45414
• Lead Sponsor: Inwendige Geneeskunde - Nefrologie en Transplantatie

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: Pending
• Sex: Not specified
• Target Recruitment: 420

Inclusion Criteria

Adult recipients (18 years or older) who were 5 to 7 years after kidney transplantation.

Exclusion Criteria

ABO-incompatible kidney transplants. Recipients of a non-renal transplant.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is donor-specific T-cell and B-cell memory function in<br /><br>relation to Tac IPV. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints:<br /><br>- The difference in the development of CRAD between in patients with high IPV<br /><br>Tac and low IPV Tac. Kidney function and CRAD will be defined by the GFR<br /><br>determined at 6 months, 1, 3, and 5 years after transplantation.<br /><br>- The T-cell receptor and B-cell receptor signature in relation to Tac IPV<br /><br>- Intra-lymphocytic Tac concentrations in relation to Tac IPV and immunologic<br /><br>parameters</p><br>