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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
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)
CIC Hopital europeen george pompidou
Paris, Paris, France
proteinuria/creatininuria ratio
Time frame: from baseline to 1 year
Number of patients with a decrease of the PU/CrU >50% ratio
Time frame: from baseline to 1 year
Evaluation of the slope of decay of the PU/CrU
Time frame: from baseline to 1 year
eGFR is estimated by the MDRD formula, and is expressed in mL/min/1.73m². The direct GFR will be assessed by measuring the 51Cr-EDTA plasmatic clearance
eGFR is estimated by the MDRD formula, and is expressed in mL/min/1.73m². The direct GFR will be assessed by measuring the 51Cr-EDTA plasmatic clearance
Time frame: from baseline to 1 year
Outcome of the GFR assessed by 51Cr-EDTA clearance
Only in the experimental arm
Time frame: from randomisation to 1 year
Decrease of the blood pressure assessed on ABPM
Time frame: From randomisation to 1 year
Anti-hypertensive regimen score
Time frame: from baseline to 1 year
Evaluation of the renal arterial anatomy
in the experimental group:number of principal renal artery. Should be 1/ kidney of at least 4mm diameter and 10mm long. One accessory artery is acceptable if \<
Time frame: from baseline to 1 year
Evaluation of safety and tolerance of renal denervation in diabetic patients with overt proteinuria
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in the experimental group:Occurrence of adverse events: acute renal failure, damage on the renal artery (dissection, perforation, thrombosis), allergy to the contrast media, worsening of any dysautonomia
Time frame: from baseline to 1 year
Evaluate the outcome of biological parameters
eGFR (MDRD formula), proteinuria/creatininuria ratio
Time frame: from baseline to 1 year
Evaluate the diabetic neuropathy/dysautonomy
in the experimental:blood pressure in orthostatism, pulse wave velocimetry, RR interval on the Holter ECG, cutaneous baroreflex
Time frame: from randomisation to 1 year
Evaluate the outcome of specific kidney injury markers
in the experimental group:urinary levels of KIM1 and NGAL before and 1 year after the denervation
Time frame: from randomisation to 1 year