NCT04916132 Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors
| NCT ID | NCT04916132 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Herlev Hospital |
| Condition | Chronic Kidney Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-08-10 |
| Primary Completion | 2043-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 300 participants in total. It began in 2021-08-10 with a primary completion date of 2043-12-31.
⚠ 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
a prospective, observational, multi-center study with a cohort of 300 patients with Type 2 diabetes and macroalbuminuria. Prospectively we will collect kidney biopsies and analyse the transciptome of the kidney tissue and other biomarkers from blood, faeces, urine, proteomic- and metabolomic profiles and DNA-variants. Thereby we hope to be able to discover molecular and clinical profiles, that can help us in the diagnosis of DKD, and to identify different risks of progression that can benefit from different forms of personalized treatment.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Written informed consent * Diagnosis with T2DM according to the American diabetes Association (20) * eGFR \>30 mL/min/1.73 m2 (maximum six months old) * urine-albumin/creatinine-ratio (uACR) \> 700 mg/g or 24 hours urine albumin \>700 mg on more than one measurement Exclusion Criteria: * Signs of acute kidney failure according to the KDIGO classification (21) at the time for kidney biopsy or the last 6 months before kidney biopsy * Factors that increases the risk of complications due to kidney biopsy: * Hemoglobin \< 6 mmol/L * INR \>1,4 at the time for biopsy * Platelet count \< 100 x 109/l * Uncontrolled high blood pressure (defined as systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg) * Only one functioning kidney * Evidence of urinary tract obstruction or hydronephrosis at the time of biopsy * Multiple bilateral kidney cysts * Kidney infection, peri-renal infection, or cutaneous infection that overlies the kidney at time for biopsy * Unwilling to receive blood transfusion * Unable to lie flat in bed six hours after biopsy * Any other contra-indications for percutaneous kidney biopsy according to local clinical guidelines * Unable to understand written and oral information * Kidney transplant recipient * Previous medical kidney biopsy * Women who are pregnant or planning to become pregnant before the kidney biopsy is performed * Treatment with Marcoumar (all other anticoagulants are accepted) * High thromboembolic risk combined with held in anticoagulation therapy according to the report "Perioperative regulation of antithrombotic treatment" (PRAB) (22) * mechanical heart valve * atrial fibrillation AND CHA2DS2-VASc\> 5 and/or stroke within the last three months * recurrent venous thromboembolism OR venous thromboembolism within the last three months * less than 6 weeks after uncomplicated Acute Coronary Syndrome (ACS) with or without revascularization (Percutaneous Coronary Intervention (PCI)) with Bare Metal Stents (BMS) or Coronary Artery Bypass Grafting (CABG)) * less than 3 months after uncomplicated ACS with revascularization (PCI with Drug Eluting Stent (DES)) * less than 9-12 months after complicated ACS (e.g. reinfarction or stent thrombosis) * less than 1 month after revascularization in individuals with stable Coronary Artery Disease (CAD) (PCI with BMS or CABG) * less than 3 months after revascularization in individuals with stable CAD (PCI with DES) * less than 3 months after stroke, or Transient Ischemic Attack (TIA) * Inability to withdraw nonsteroidal anti-inflammatory drugs (NSAID) 7 days before biopsy If a participant meets one or more exclusion criteria, that are reversible, the participant can be rescreened later on, to evaluate whether or not the participant now is qualified for participation.
Contact & Investigator
Frederik Persson, MD, PhD
STUDY CHAIR
Steno Diabetes Center Copenhagen
Frequently Asked Questions
Who can join the NCT04916132 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04916132 currently recruiting?
Yes, NCT04916132 is actively recruiting participants. Contact the research team at marie.moeller@regionh.dk for enrollment information.
Where is the NCT04916132 trial being conducted?
This trial is being conducted at Skejby, Denmark, Copenhagen, Denmark, Hillerød, Denmark, Holbæk, Denmark and 9 additional locations.
Who is sponsoring the NCT04916132 clinical trial?
NCT04916132 is sponsored by Herlev Hospital. The principal investigator is Frederik Persson, MD, PhD at Steno Diabetes Center Copenhagen. The trial plans to enroll 300 participants.
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