Renal Denervation in Patients With Diabetic Nephropathy and Persistent Proteinuria (DERENEDIAB)

NCT01588795 Phase 4 COMPLETED

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 4
Status	COMPLETED
Enrolment	25
Start date	2012-04
Completion	2016-01

Conditions

• Diabetic Nephropathy
• Persistent Proteinuria With Type II Diabetes

Interventions

• Percutaneous renal denervation and TMNS
• Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin

Primary outcomes

• proteinuria/creatininuria ratio — from baseline to 1 year

Countries

France