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Renal Denervation in Diabetic Nephropathy

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Nephropathy; Persistent Proteinuria With Type II Diabetes

Intervention: Percutaneous renal denervation and TMNS (Procedure); Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Guillaume Bobrie, MD, Principal Investigator, Affiliation: HTA department

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.

Clinical Details

Official title: Renal Denervation in Patients With Diabetic Nephropathy and Persistent Proteinuria

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: proteinuria/creatininuria ratio

Secondary outcome:

Number of patients with a decrease of the PU/CrU >50% ratio

Evaluation of the slope of decay of the PU/CrU

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

Outcome of the GFR assessed by 51Cr-EDTA clearance

Decrease of the blood pressure assessed on ABPM

Anti-hypertensive regimen score

Evaluation of the renal arterial anatomy

Evaluation of safety and tolerance of renal denervation in diabetic patients with overt proteinuria

Evaluate the outcome of biological parameters

Evaluate the diabetic neuropathy/dysautonomy

Evaluate the outcome of specific kidney injury markers

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

- Patient with transient or fixed cerebral ischemia within 3 months before inclusion

- Patient with myocardial infarction, unstable angina pectoris, coronary bypass or

percutaneous angioplasty within 3 months before inclusion

- Patient with asthma or chronic obstructive pulmonary disease with a contra-indication

to beta-blockers medication

- Patient with type 1 diabetes mellitus

- Uncontrolled type 2 diabetes mellitus (Hb1Ac > 10%)

- Patient with malignancy within the 5 past years

- Patient with any medical or surgical condition that could worsen the risk of the

study, according to the investigator; Patient with chronic alcohol consumption

- Patient with atrial fibrillation and/or a brachial circumference of ≥ 42cm

- Patient is pregnant, nursing or planning to be pregnant

Locations and Contacts

CIC Hopital europeen george pompidou, Paris 75015, France
Additional Information

Starting date: April 2012
Last updated: April 2, 2015

Page last updated: August 23, 2015

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