Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors (NCT04916132) | Clinical Trial Compass
RecruitingNot Applicable
Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors
Denmark300 participantsStarted 2021-08-10
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence
Timeframe: From baseline to end inclusion (3 years)