Renal Denervation in Patients With Diabetic Nephropathy and Persistent Proteinuria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- proteinuria/creatininuria ratio
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Denervation + TMNS
Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
干预措施: Percutaneous renal denervation and TMNS (Procedure)
TMNS
Patients are maintained on standardized anti-proteinuric medications
干预措施: Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin (Drug)
结局指标
主要结局
proteinuria/creatininuria ratio
时间窗: from baseline to 1 year
次要结局
- 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)