MRI in Renal Transplantation

NCT03705091 | Unknown

• 1 other identifier: GN15RE038
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Renal transplantation is the optimal method of treatment for end stage kidney disease however median lifespan of a kidney transplant is around 15 years. Existing methods of measuring transplant function and structure from blood and urine markers are imperfect; renal biopsy is often performed but is invasive. Novel methods of investigating transplant function are therefore required and emerging renal MRI sequences including ASL and diffusion weighted imaging may yield helpful biomarkers. Investigators will recruit 20 patients in the first year after transplant and measure MRI biomarkers at three time points, with correlation to existing methods of measuring transplant function.

Conditions

End Stage Renal Disease; Renal Transplant Rejection; Kidney Transplant Failure and Rejection; Chronic Kidney Diseases

Keywords

Magnetic resonance imaging; Biomarkers; Arterial spin labelling; Diffusion weighted imaging; Renal transplantation

Outcome Measures

Primary Outcomes (1)

• Change in arterial spin labelling (ASL)

  Renal perfusion measured by ASL MRI

  Measured at 2, 6, 12 months after transplant

Secondary Outcomes (1)

• Change in apparent diffusion coefficient (ADC)

  Measured at 2, 6, 12 months after transplant

Study Arms (1)

Transplant

Incident patients receiving a kidney transplant for end stage kidney disease. Patients will undergo functional magnetic resonance imaging at 2 months, 6 months and 12 months following transplantation.

Diagnostic Test: Magnetic resonance imaging

Interventions

Magnetic resonance imaging DIAGNOSTIC_TEST

ASL and DWI MRI

Transplant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have either recently received, or are undergoing assessment for kidney transplantation, will be recruited. Those receiving live donor transplants undergo surgery electively and can be approached prior to the time of transplant. Those receiving kidney transplants from the waiting list represent the majority of transplant patients, and undergo surgery at unpredictable time points depending on the availability of organs. These individuals will be approached shortly after transplantation. They will be identified from the electronic medical record and approached at the transplant assessment clinic or on the transplant ward. A participant information sheet will be given and the patient contacted after one week to confirm or refute participation.

You may qualify if:

• Age \> 18 years
• Recent or pending kidney transplantation
• Written informed consent

You may not qualify if:

• Severe chronic liver, heart or lung disease
• Chronic infection
• Unable to give valid informed consent
• Known pregnancy or intent to conceive during the study period
• Any contraindicating to MRI

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

University of Glasgow

Glasgow, Renfrewshire, G12 8TA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Rejection, Psychology; Renal Insufficiency, Chronic

Interventions

Magnetic Resonance Imaging

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; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Keith Gillis, MBChB PhD

CONTACT

0141 330 2409; keithgillis@nhs.net

Study Design

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

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: October 15, 2018
• Study Start: April 11, 2017
• Primary Completion: February 20, 2019
• Study Completion: March 20, 2019
• Last Updated: October 15, 2018

Record last verified: 2018-02

Locations

GB (1)