NCT03716401 Prognostic Imaging Biomarkers for Diabetic Kidney Disease
| NCT ID | NCT03716401 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leeds |
| Condition | Diabetic Kidney Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2018-09-01 |
| Primary Completion | 2022-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2018-09-01 with a primary completion date of 2022-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Transplantation (except corneal); * On permanent dialysis; * Significant comorbidities with life expectancy of \< 1 year; * Use of investigational drug within 1 month prior to screening; * 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; * Current pregnancy; * History of Hepatitis B or Hepatitis C +; * Use of antiretroviral medication; * Known current or clinical history of renal or urinary tract malignancy; * Concurrent other renal disease (suspected or proven); * Cirrhotic liver disease, or non-cirrhotic chronic liver disease where ALT \>2 x upper limit of normal; * Current metastatic malignancy; * Current malignancy with expected survival \< study follow up period (4 years); * Melanomatous skin cancer \< 5 years ago (fully resected melanoma \>5 years ago, i.e. surgical cure, can be recruited); * 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; * Cochlear Implant; * Aneurysm Clips; * Neurological stimulator; * Implanted cardiac devices (ICD, PPM, loop recorders, or any others); * Metal heart valve; * History of metal foreign bodies in orbits; * Other implanted metal device which prevents MR imaging; * Known allergy to Gadolinium contrast; * Claustrophobia; * Weight exceeding 250 kg; * \[Bari arm\] Absolute contraindications to percutaneous renal biopsy; * \[Bari arm\] Bleeding diathesis; * \[Bari arm\] Severe uncontrolled hypertension; * \[Bari arm\] End stage renal disease with small hyperechoic kidneys;
Contact & Investigator
Steven sourbron
STUDY CHAIR
University of Leeds
Frequently Asked Questions
Who can join the NCT03716401 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Diabetic Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03716401 currently recruiting?
Yes, NCT03716401 is actively recruiting participants. Contact the research team at s.sourbron@leeds.ac.uk for enrollment information.
Where is the NCT03716401 trial being conducted?
This trial is being conducted at Turku, Finland, Bordeaux, France, Bari, Italy, Malmö, Sweden and 3 additional locations.
Who is sponsoring the NCT03716401 clinical trial?
NCT03716401 is sponsored by University of Leeds. The principal investigator is Steven sourbron at University of Leeds. The trial plans to enroll 500 participants.
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