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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03780101
Other study ID # GN18RE474
Secondary ID 248675
Status Terminated
Phase
First received
Last updated
Start date February 15, 2019
Est. completion date May 24, 2022

Study information

Verified date May 2022
Source NHS Greater Glasgow and Clyde
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 29
Est. completion date May 24, 2022
Est. primary completion date May 24, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Diagnostic Test:
Multi-parametric renal MRI
Multi-parametric functional magnetic resonance imaging of a transplant kidney including sequences for T1, T2, diffusion-weighted imaging, diffusion tensor imaging and arterial spin labelling.

Locations

Country Name City State
United Kingdom NHS Greater Glasgow & Clyde Glasgow

Sponsors (1)

Lead Sponsor Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of MRI biomarkers for fibrosis with histology Correlation between diffusion weighted imaging on renal MRI and reported percentage of cortical area on biopsy showing interstitial fibrosis. Baseline
Secondary Renal MRI following treatment for acute rejection Correlation between change in native T1 and serum creatinine following treatment for acute rejection. 2 weeks
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