Diabetic Kidney Disease Clinical Trial
— iBEAtOfficial title:
Prognostic Imaging Biomarkers for Diabetic Kidney Disease
NCT number | NCT03716401 |
Other study ID # | 219542 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2018 |
Est. completion date | September 1, 2038 |
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 | Recruiting |
Enrollment | 500 |
Est. completion date | September 1, 2038 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
Finland | Turun Yliopisto | Turku | |
France | Centre Hospitalier Universitaire de Bordeaux | Bordeaux | |
Italy | Università degli Studi di Bari Aldo Moro | Bari | Puglia |
Sweden | Lund University Diabetes Centre | Malmö | |
Switzerland | Swiss Institute of Bioinformatics | Lausanne | |
United Kingdom | University of Exeter | Exeter | |
United Kingdom | University of Leeds | Leeds |
Lead Sponsor | Collaborator |
---|---|
University of Leeds | Lund University, Swiss Institute of Bioinformatics, University Hospital of Bordeaux, University of Bari, University of Exeter, University of Turku |
Finland, France, Italy, Sweden, Switzerland, United Kingdom,
Grenier N, Merville P, Combe C. Radiologic imaging of the renal parenchyma structure and function. Nat Rev Nephrol. 2016 Jun;12(6):348-59. doi: 10.1038/nrneph.2016.44. Epub 2016 Apr 12. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Turku PET Cohort - Renal Blood Flow | Renal Blood Flow measured by Water-labelled PET/MRI | 2 years | |
Other | Bari Biopsy Cohort - Total number of glomeruli | Total number of glomeruli measured on renal histopathology | 2 years | |
Other | Leeds Microstructure MRI Cohort - Novel biomarkers of renal microstructure | Novel biomarkers of renal microstructure measured with Diffusion Tensor Imaging and 3D Dynamic Contrast-Enhanced MRI | 2 years | |
Other | Bordeaux MRI Follow-up Cohort - two-year rate of change in MRI biomarkers and radiomic signatures | Two-year rate of change in MRI biomarkers and radiomic signatures | 4 years | |
Other | Exeter Microvasculature Assessment Cohort - Thickness of the sublingual glycocalyx | Thickness of the sublingual glycocalyx as measured by Glycocheck imaging | 4 years | |
Primary | Cross-sectional (multi-centre collaboration) | MRI biomarkers will be combined with fluid-based biomarkers to discover radiomics features that correlate with renal function | 2 years | |
Secondary | Longitudinal (multi-centre collaboration) | MRI biomarkers will be combined with patient follow-up data to discover radiomics features that correlate with disease progression | 4 years |
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