NCT01588795

Renal Denervation in Diabetic Nephropathy

Renal Denervation in Patients With Diabetic Nephropathy and Persistent Proteinuria

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Nephropathy
• Persistent Proteinuria With Type II Diabetes

Interventions

Type	Name	Description
PROCEDURE	Percutaneous renal denervation and TMNS	Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
DRUG	Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin	Patients are maintained on Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker (irbesartan 300mg), a diuretic (furosemide 40mg or indapamide LP 1.5mg according to the eGFR), 25OH vitamin D3 and a statin (atorvastatin 20mg)

Timeline

• Start date: 2012-04-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2012-05-01
• Last updated: 2016-06-01

Locations

1 site across 1 country: France