NCT03716401Recruiting

Prognostic Imaging Biomarkers for Diabetic Kidney Disease

Source: ClinicalTrials.gov · Last updated 11 Jan 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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. 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.

Status (registry): Recruiting
Study type: Observational
Enrollment: 500 (estimated)
First submitted: 1 Mar 2018
Start date: 1 Sept 2018
Primary completion date: 1 Sept 2022
Lead sponsor: University of Leeds
Diseases: Chronic kidney disease
NCT number: NCT03716401

What you commit to

Study type: Observational
Planned participants: 500
From 1 Sept 2018 to the primary completion date, 1 Sept 2022
7 sites in 6 countries
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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;

Other illness

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;

Lab values

Cirrhotic liver disease, or non-cirrhotic chronic liver disease where ALT \>2 x upper limit of normal;

Age

Melanomatous skin cancer \< 5 years ago (fully resected melanoma \>5 years ago, i.e. surgical cure, can be recruited);

Other

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;

Who the study is looking for

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).

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Swiss Institute of Bioinformatics Coordinator of this site? Confirm its status	Lausanne	Switzerland	Active, not recruiting
Turun Yliopisto Coordinator of this site? Confirm its status	Turku	Finland	Recruiting
Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status	Bordeaux	France	Not yet recruiting
University Of Exeter Coordinator of this site? Confirm its status	Exeter	United Kingdom	Not yet recruiting
University of Leeds Coordinator of this site? Confirm its status	Leeds	United Kingdom	Recruiting
Università degli Studi di Bari Aldo Moro Coordinator of this site? Confirm its status	Bari	Italy	Not yet recruiting
Lund University Diabetes Centre Coordinator of this site? Confirm its status	Malmö	Sweden	Active, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.