Developing a non-invasive method for the diagnosis and monitoring of kidney transplant rejectio

Not Applicable

• Conditions: End stage kidney disease; Kidney transplantation; Kidney transplant rejection; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12621000898853
• Lead Sponsor: Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-09
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

(1)Incident patients undergoing live donor or deceased donor kidney transplantation at the Royal Melbourne Hospital; OR
(2)Patients not recruited at the time of transplant but undergoing a ‘for-cause’ transplant kidney biopsy

Exclusion Criteria

(1) Patients who are unable or unwilling to provide consent to participate in the study.

(2) Patients who will not be able to attend this centre (Royal Melbourne Hospital) for follow up over the study period (cohort 1 only).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the urinary proteome associated with kidney transplant rejection:<br><br>The urinary proteome will be assessed by shot-gun mass spectrometry with changes in the proteome associated with kidney transplant rejection determined by correlation with kidney transplant biopsy results assessed as per the BANFF diagnostic criteria.[Cohort 1:<br>0-3 months post-transplant: weekly<br>3-6 months post-transplant: every 2 weeks<br>6-9 months post-transplant: every 3 weeks<br>9-12 months post-transplant: every 4 weeks<br><br>Cohort 2:<br>A single sample at the time of an indication kidney transplant biopsy]