Pathology and Imaging in Kidney Allografts

Terminated

• Conditions: Chronic Kidney Diseases; Fibrosis; Renal Transplant Rejection

• Registration Number: NCT03780101
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

This study will perform multi-parametric renal MRI in 70 patients with a renal transplant who are undergoing a clinically indicated biopsy of their transplant. The aim of this study is to compare findings on renal MRI with those seen on histology.

Detailed Description

Background: Renal transplantation is the optimal treatment for patients with renal failure. However, transplant life-span is finite and commonly limited due to the development of chronic rejection and other causes of irreversible fibrosis. At present, renal transplant biopsy is required to diagnose the cause of transplant dysfunction. Renal biopsies are invasive procedures that carry risks of bleeding, damage to the transplant and discomfort to patients. Functional magnetic resonance imaging (MRI) of the kidneys is an emerging field of research that has potential to non-invasively define and quantify parenchymal renal disease including fibrosis and inflammation. There is a paucity of data correlating multi-parametric renal MRI sequences with histological findings on biopsy, especially in patients with renal transplants.

Study participants: 70 adult renal transplant recipients who have been referred for a clinically indicated biopsy of their transplant kidney.

Study design: Participants will undergo multi-parametric renal MRI at time of biopsy. In patients who receive treatment for acute rejection, a second renal MRI will be undertaken at completion of treatment. Blood tests for fibrosis biomarkers and routine clinical measures of transplant function will be obtained at time of MRI scanning.

Objectives:

1. Assess the correlation between functional renal MRI sequences and histological markers of fibrosis and inflammation.

2. Assess the change in functional MRI sequences in response to treatment for acute rejection in renal transplant recipients.

Study Timeline

• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-02-15
• Status Verified: 2022-05
• Primary Completion: 2022-05-24
• Study Completion: 2022-05-24
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Age > 18 years
• Recipient of a kidney transplant
• Referred for clinically indicated biopsy of transplant kidney
• Ability to comply with study procedures.
• Ability to give informed consent.

Exclusion Criteria

• Any contraindication to MRI
• Known pregnancy or intent to conceive during the study period
• Clinical suspicion of delayed graft function as the cause of transplant dysfunction
• Any other reason considered by a study physician to make the subject inappropriate for inclusion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of MRI biomarkers for fibrosis with histology	Baseline	Correlation between diffusion weighted imaging on renal MRI and reported percentage of cortical area on biopsy showing interstitial fibrosis.

Secondary Outcome Measures

Name	Time	Method
Renal MRI following treatment for acute rejection	2 weeks	Correlation between change in native T1 and serum creatinine following treatment for acute rejection.

Trial Locations

Locations (1)

NHS Greater Glasgow & Clyde; 🇬🇧 Glasgow, United Kingdom