Pathology and Imaging in Kidney Allografts

Chronic Kidney Diseases Clinical Trial

— PIKA  

Official title:

Pathology and Imaging in Kidney Allografts

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03780101
• Other study ID #: GN18RE474
• Secondary ID: 248675
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Fibrosis
• Kidney Diseases
• Renal Insufficiency, Chronic
• Renal Transplant Rejection

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