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Pathology and Imaging in Kidney Allografts

Pathology and Imaging in Kidney Allografts

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03780101
Acronym
PIKA
Enrollment
29
Registered
2018-12-19
Start date
2019-02-15
Completion date
2022-05-24
Last updated
2022-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Fibrosis, Renal Transplant Rejection

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.

Interventions

DIAGNOSTIC_TESTMulti-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.

Sponsors

NHS Greater Glasgow and Clyde
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of MRI biomarkers for fibrosis with histologyBaselineCorrelation between diffusion weighted imaging on renal MRI and reported percentage of cortical area on biopsy showing interstitial fibrosis.

Secondary

MeasureTime frameDescription
Renal MRI following treatment for acute rejection2 weeksCorrelation between change in native T1 and serum creatinine following treatment for acute rejection.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026