Renal Denervation in Diabetic Nephropathy

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Angiotensin Receptor Antagonists; Cholecalciferol; Diuretics; Vitamin D; Vitamins

Criteria

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 myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion

• Patient with asthma or chronic obstructive pulmonary disease with a contra-indication to beta-blockers medication

• Patient with type 1 diabetes mellitus

• Uncontrolled type 2 diabetes mellitus (Hb1Ac > 10%)

• Patient with malignancy within the 5 past years

• Patient with any medical or surgical condition that could worsen the risk of the study, according to the investigator; Patient with chronic alcohol consumption

• Patient with atrial fibrillation and/or a brachial circumference of ≥ 42cm

• Patient is pregnant, nursing or planning to be pregnant