drugset / Trial / NCT01588795

Renal Denervation in Diabetic Nephropathy

NCT01588795

Phase 4 Completed 25 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-04
Primary completion
2016-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atorvastatin Small molecule 20 mg
Comparator Cholecalciferol Other / unclassified
Comparator Furosemide Other / unclassified 40 mg
Comparator Indapamide Small molecule 1.5 mg
Comparator Irbesartan Small molecule 300 mg