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% ratioEvaluation 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
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