Renal Denervation in Patients With Diabetic Nephropathy and Persistent Proteinuria
Overview
- Phase
- Phase 4
- Intervention
- Percutaneous renal denervation and TMNS
- Conditions
- Diabetic Nephropathy
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- proteinuria/creatininuria ratio
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Denervation + TMNS
Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
Intervention: Percutaneous renal denervation and TMNS
TMNS
Patients are maintained on standardized anti-proteinuric medications
Intervention: Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin
Outcomes
Primary Outcomes
proteinuria/creatininuria ratio
Time Frame: from baseline to 1 year
Secondary Outcomes
- 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(from baseline to 1 year)
- Outcome of the GFR assessed by 51Cr-EDTA clearance(from randomisation to 1 year)
- Number of patients with a decrease of the PU/CrU >50% ratio(from baseline to 1 year)
- Evaluation of the slope of decay of the PU/CrU(from baseline to 1 year)
- Evaluation of the renal arterial anatomy(from baseline to 1 year)
- Decrease of the blood pressure assessed on ABPM(From randomisation to 1 year)
- Anti-hypertensive regimen score(from baseline to 1 year)
- Evaluation of safety and tolerance of renal denervation in diabetic patients with overt proteinuria(from baseline to 1 year)
- Evaluate the outcome of biological parameters(from baseline to 1 year)
- Evaluate the diabetic neuropathy/dysautonomy(from randomisation to 1 year)
- Evaluate the outcome of specific kidney injury markers(from randomisation to 1 year)