Pathology and Imaging in Kidney Allografts

NCT03780101 | Terminated

• 2 other identifiers: GN18RE474248675
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplant Rejection; Chronic Kidney Diseases; Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Renal MRI following treatment for acute rejection

  2 weeks

Interventions

Multi-parametric renal MRI DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Renal transplant recipients referred for a clinically-indicated biopsy of their transplant kidney

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fibrosis biomarkers, which may include galactin-3, microRNA (including miR-214, miR-21 and miR-29), tissue inhibitor metalloproteinases (TIMP)

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Fibrosis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alastair J Rankin, MBChB

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: February 15, 2019
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

GB (1)