MRI in Renal Transplantation

Chronic Kidney Diseases Clinical Trial

— TransRASL  

Official title:

Non Contrast Magnetic Resonance Imaging to Measure Renal Transplant Perfusion and Fibrosis - Association With Function and Prognosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03705091
• Other study ID #: GN15RE038
• Status: Recruiting
• Start date: April 11, 2017
• Est. completion date: March 20, 2019

Study information

• Verified date: February 2018
• Source: NHS Greater Glasgow and Clyde
• Contact: Keith Gillis, MBChB PhD
• Phone: 0141 330 2409
• Email: keithgillis[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Kidney transplantation remains the optimal therapy for patients with end stage kidney disease and is associated with significant improvements in life expectancy and quality of life compared to subjects receiving dialysis. Despite significant advances in our understanding of the immune system and development of drugs to prolong transplant function, a large number (Scottish Renal Registry data suggest between 23-35%) of transplants fail in the 10 years from operation. This may be due to a number of factors but is often due to development of transplant rejection, where the recipient's immune system damages the transplant. Early recognition and implementation of therapy is needed to dampen this response, reduce irreversible damage and preserve transplant function.

At present, transplant function and damage is measured using blood and urine tests. These are far from perfect markers because there is a delay between transplant damage and abnormalities of these tests. This time is vital for the short and long term survival of the transplant.

In the University of Glasgow, investigators have developed a new type of magnetic resonance imaging (MRI) which allows assessment of kidney blood flow and fibrosis (scarring) without the need for administration of harmful contrast agents. Arterial spin labelling magnetic resonance imaging (ASL MRI) is a non-invasive method of measuring renal perfusion using magnetised blood as endogenous contrast and investigators have validated this technique previously in both individuals with and without kidney disease. Diffusion tensor imaging (DTI) is another modality of non-contrast MRI which allows measurement of 'stiffness' of renal transplants, which represents long term scarring and fibrosis.

The investigators intend to follow up people receiving a kidney transplant for one year, collecting samples of blood, urine, and performing MR imaging at 3 time points, in order to investigate novel biomarkers of transplant function and dysfunction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 20, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age > 18 years

• Recent or pending kidney transplantation

• Written informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Kidney Transplant Failure and Rejection
• Renal Insufficiency, Chronic
• Renal Transplant Rejection

Intervention

Diagnostic Test:
• Magnetic resonance imaging
ASL and DWI MRI

Locations

Country	Name	City	State
United Kingdom	University of Glasgow	Glasgow	Renfrewshire

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	Change in arterial spin labelling (ASL)	Renal perfusion measured by ASL MRI	Measured at 2, 6, 12 months after transplant
Secondary	Change in apparent diffusion coefficient (ADC)	Renal fibrosis measured by diffusion weighted imaging (DWI) MRI	Measured at 2, 6, 12 months after transplant