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Imaging Scans to Predict Kidney Decline in Diabetic Kidney Disease

Studies whether kidney MRI and ultrasound scans can predict worsening in early diabetic kidney disease.

Key facts

Who runs it: University of Leeds
Where: Bari, ItalySee the siteAlso in 5 other countries, 6 sites
Trial code: NCT03716401
Registry title: Prognostic Imaging Biomarkers for Diabetic Kidney Disease
Status: Recruiting
People taking part: 500 people, planned
Started: 1 Sept 2018
Expected to end: 1 Sept 2038
Type of study: Observational, 5 groups
Treatments tested: MRI (magnetic resonance imaging)
US (ultrasound)
Renal Biopsy
Positron Emission Tomography (PET)
Microvascular Assessment
Record updated: 11 January 2021

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes and early-stage diabetic kidney disease. It uses kidney scans to see who is likely to get worse.

Age: 18 to 80 years
Sex: All sexes can join.
Disease stage: Type 2 diabetes with kidney function (eGFR) of 30 ml/min/1.73m2 or higher. The study describes early stage diabetic kidney disease.
Earlier treatment: Diabetes and blood pressure medicines must have stayed the same for the past 3 months (dose changes are allowed). No investigational drug in the 1 month before screening.

Main reasons for not taking part

Any organ transplant (except corneal) or permanent dialysis
Current pregnancy
Metal implants or devices that prevent MRI, or claustrophobia
Known allergy to Gadolinium contrast
Other kidney disease or kidney or urinary tract cancer

The registry criteria, word for word

Show all 35 criteriaShow less

Who can take part

Diagnosis Diabetes Type 2
eGFR >= 30 ml/min/1.73m2
Able to provide informed consent
Age between 18 years and 80 years
Unchanged antidiabetic and antihypertensive medication for the past 3 months (not including dose changes)

Who cannot take part

Transplantation (except corneal)
Use of investigational drug within 1 month prior to screening
Use of antiretroviral medication
Concurrent other renal disease (suspected or proven)
Cochlear Implant
Known clinical history of urinary obstruction on renal US: either post-voiding residue over 100 ml, or pyelectasis
Known clinical history of aortic endoprosthesis at the renal level
History of Hepatitis B or Hepatitis C +
Known current or clinical history of renal or urinary tract malignancy
Current metastatic malignancy
Current malignancy with expected survival < study follow up period (4 years)
Any other significant disease or disorder which, in the opinion of the investigators, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study
Implanted cardiac devices (ICD, PPM, loop recorders, or any others)
Metal heart valve
History of metal foreign bodies in orbits
Known allergy to Gadolinium contrast
[Bari arm] Bleeding diathesis
[Bari arm] Severe uncontrolled hypertension
[Bari arm] End stage renal disease with small hyperechoic kidneys
Cirrhotic liver disease, or non-cirrhotic chronic liver disease where ALT >2 x upper limit of normal
Melanomatous skin cancer < 5 years ago (fully resected melanoma >5 years ago, i.e. surgical cure, can be recruited)
On permanent dialysis
Significant comorbidities with life expectancy of < 1 year
Current pregnancy
Aneurysm Clips
Neurological stimulator
Other implanted metal device which prevents MR imaging
Claustrophobia
Weight exceeding 250 kg
[Bari arm] Absolute contraindications to percutaneous renal biopsy

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 80 years old?

Where in Italy

Also in 5 other countries, 6 sites

Università degli Studi di Bari Aldo MoroBari, ItalyContact: Massimo Papale, PhDNot yet recruiting

About the trial

What the trial wants to find out

Diabetic kidney disease (DKD) is a common complication of diabetes, and is now the most common form of chronic kidney disease. DKD is the leading cause of kidney disease requiring dialysis or kidney transplantation, and its global incidence and prevalence have reached epidemic levels. While the risk of developing DKD can be ameliorated by tight blood glucose and blood pressure control, it is not fully preventable and once established DKD cannot be cured. Therefore many patients are left with poor and worsening health and with increased mortality risk. Developing new ways to treat DKD requires healthcare professionals to be able to identify those patients most in need of treatment.

Read full original descriptionShow less

One promising approach for identifying patients that are at risk is the use of imaging measurements (called "biomarkers") derived from Magnetic Resonance Imaging (MRI) and Ultrasound (US) of the kidneys. Evidence from early studies shows that such imaging biomarkers can identify underlying problems in DKD such as blood supply, oxygen supply, kidney scarring and kidney function, in ways that are better than those currently available.

The investigators think that imaging biomarkers will improve the identification of patients who are likely to decline from DKD in the short term. The changes found by imaging may even happen before effects on the blood and urine.

The investigators plan to test this hypothesis by performing a study observing 500 patients with early stage DKD, recruited in 5 sites across Europe. All patients will have detailed assessment at the start of their involvement, including clinical assessment, blood and urine samples, and MRI and US scans. The investigators will look at whether imaging biomarkers are associated with other measures that predict progression in DKD, and follow patients every year for 3 years (4 years total study participation) to see if the imaging biomarkers predict worsening DKD.

The 5 groups in the trial

Bari: Biopsy Arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples. Additionally, participants at the Bari site will have an additional renal biopsy at baseline.
Treatment: MRI (magnetic resonance imaging), US (ultrasound), and Renal Biopsy
Bordeaux: MRI Follow-up arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples. Additionally, participants at the Bordeaux site will have an additional ultrasound US and MRI in Follow-up year 2.
Treatment: MRI (magnetic resonance imaging) and US (ultrasound)
Exeter: Microvascular arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples. Participants at the Exeter site will undergo microvascular measurements including estimating glycocalyx thickness at baseline and at 2 years follow-up.
Treatment: MRI (magnetic resonance imaging), US (ultrasound), and Microvascular Assessment
Leeds: Microstructure MRI arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. Participants at the Leeds' site will have an extended MRI scan at baseline including novel microstructure MRI measurements.
Treatment: MRI (magnetic resonance imaging) and US (ultrasound)
Turku: PET arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples. Additionally, participants at the Turku site will undergo a renal Positron Emission Tomography (PET) scan at the baseline timepoint.
Treatment: MRI (magnetic resonance imaging), US (ultrasound), and Positron Emission Tomography (PET)