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 range18 Years – 75 Years
SexALL
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…