Renal Denervation in Diabetic Nephropathy (DERENEDIAB)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 4

Conditions

Diabetic Nephropathy

Persistent Proteinuria With Type II Diabetes

Treatments

Procedure: Percutaneous renal denervation and TMNS

Drug: Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin

Study type

Interventional

Funder types

Other

Identifiers

NCT01588795

P110122

Details and patient eligibility

About

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.

Full description

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.

Enrollment

25 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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