Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03705091
Other study ID # GN15RE038
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT06386172 - Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm N/A
Recruiting NCT04910867 - APOL1 Genetic Testing Program for Living Donors N/A
Completed NCT03434145 - Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases N/A
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Terminated NCT05022329 - COVID-19 Vaccine Boosters in Patients With CKD Phase 2/Phase 3
Not yet recruiting NCT04925661 - HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia Phase 1
Recruiting NCT04961164 - Resistant Starch Prebiotic Effects in Chronic Kidney Disease N/A
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Completed NCT03426787 - Helping Empower Liver and Kidney Patients N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Completed NCT04363554 - The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease N/A
Recruiting NCT04831021 - Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role? N/A
Terminated NCT04877847 - Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury N/A
Recruiting NCT04422652 - Combination of Novel Therapies for CKD Comorbid Depression Phase 2
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Not yet recruiting NCT06330480 - Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease N/A
Recruiting NCT03176862 - Left Ventricular Fibrosis in Chronic Kidney Disease N/A
Terminated NCT02539680 - Intestinal Phosphate Transporter Expression in CKD Patients N/A