Clinical trial NCT03780101: Pathology and Imaging in Kidney Allografts
Official title: Pathology and Imaging in Kidney Allografts
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Renal Transplant Rejection
Chronic Kidney Diseases
Fibrosis
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal transplant recipients referred for a clinically-indicated biopsy of their transplant kidney

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of MRI biomarkers for fibrosis with histology
timeFrame: Baseline
Secondary outcomes:
measure: Renal MRI following treatment for acute rejection
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow & Clyde
Study officials:
affiliation: University of Glasgow
name: Alastair J Rankin, MBChB
role: PRINCIPAL_INVESTIGATOR
References: