Renal Denervation in Diabetic Nephropathy (NCT01588795) | Clinical Trial Compass
CompletedPhase 4
Renal Denervation in Diabetic Nephropathy
France25 participantsStarted 2012-04
Plain-language summary
The DERENEDIAB study is a proof-of-concept, multi-center, prospective, open, randomized, controlled study of the effectiveness of renal denervation in addition to standardized medical treatment compared to medical treatment alone in diabetic subjects with diabetic nephropathy and resistant proteinuria. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
Who can participate
Age range
18 Years – 75 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:
* Type 2 diabetes mellitus male or female patient
* Individual is \> 18 and ≤ 75 years old
* Diabetic nephropathy (if no pathological examination, diagnosis based on the association of history of diabetes, diabetic retinopathy and no hematuria)
* Proteinuria/creatininuria ratio \> 0.1 g/mmol lasting for 8 weeks
* Under stable medication regimen including for at least 2 months full tolerated doses of al least 1 RAAS blocker (ACEI, renin inhibitor, ARB) and a diuretic
* 2 functional kidneys sizing ≥ 90 mm; eGFR \> 20 mL/min/1.73m² (MDRD formula
* Suitable aorto-renal vascular anatomy compatible with the endovascular denervation procedure; Informed consent has been signed
* Health insurance policy active
Exclusion Criteria:
* Patients with an estimated glomerular filtration rate (eGFR) of less than 20 mL/min/1.73 m2
* Patients unable to sign an informed consent, to understand the protocol, living too far from the specialized center
* Non-diabetic renal disease
* Patients with severe hypertension (grade 3 ESH classification)
* Kaliemia ≥ 6mmol/L
* History of nephrogenic fibrosis-induced MRI contrast media
* Patient with single functioning kidney
* Patient with contrast media allergy
* Patient with any implantable device incompatible with low frequency waves delivery
* Patient with contra-indication to the anti-proteinuric standardized medication regimen
* Patient with transient or fixed cerebral ischemia within 3 months before inclusion
* Patient with myoca…
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.