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Renal Denervation in Diabetic Nephropathy (DERENEDIAB)

2016年5月30日 更新者：Assistance Publique - Hôpitaux de Paris

Renal Denervation in Patients With Diabetic Nephropathy and Persistent Proteinuria

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

25

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 法国
      • Paris、法国、75015
        • CIC Hopital europeen george pompidou

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Denervation + TMNS
Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
程序：Percutaneous renal denervation and TMNS
Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
有源比较器：TMNS
Patients are maintained on standardized anti-proteinuric medications
药品：Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin
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)

研究衡量的是什么？

主要结果指标

结果测量
大体时间
proteinuria/creatininuria ratio
大体时间：from baseline to 1 year
from baseline to 1 year

次要结果测量

结果测量
措施说明
大体时间
Number of patients with a decrease of the PU/CrU >50% ratio
大体时间：from baseline to 1 year
from baseline to 1 year
Evaluation of the slope of decay of the PU/CrU
大体时间：from baseline to 1 year
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
大体时间：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
from baseline to 1 year
Outcome of the GFR assessed by 51Cr-EDTA clearance
大体时间：from randomisation to 1 year
Only in the experimental arm
from randomisation to 1 year
Decrease of the blood pressure assessed on ABPM
大体时间：From randomisation to 1 year
From randomisation to 1 year
Anti-hypertensive regimen score
大体时间：from baseline to 1 year
from baseline to 1 year
Evaluation of the renal arterial anatomy
大体时间：from baseline to 1 year
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 <
from baseline to 1 year
Evaluation of safety and tolerance of renal denervation in diabetic patients with overt proteinuria
大体时间：from baseline to 1 year
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
from baseline to 1 year
Evaluate the outcome of biological parameters
大体时间：from baseline to 1 year
eGFR (MDRD formula), proteinuria/creatininuria ratio
from baseline to 1 year
Evaluate the diabetic neuropathy/dysautonomy
大体时间：from randomisation to 1 year
in the experimental:blood pressure in orthostatism, pulse wave velocimetry, RR interval on the Holter ECG, cutaneous baroreflex
from randomisation to 1 year
Evaluate the outcome of specific kidney injury markers
大体时间：from randomisation to 1 year
in the experimental group:urinary levels of KIM1 and NGAL before and 1 year after the denervation
from randomisation to 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Assistance Publique - Hôpitaux de Paris

调查人员

  • 首席研究员：Guillaume Bobrie, MD、HTA department

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年4月1日

初级完成 (实际的)

2016年1月1日

研究完成 (实际的)

2016年1月1日

研究注册日期

首次提交

2012年4月18日

首先提交符合 QC 标准的

2012年4月27日

首次发布 (估计)

2012年5月1日

研究记录更新

最后更新发布 (估计)

2016年6月1日

上次提交的符合 QC 标准的更新

2016年5月30日

最后验证

2016年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • P110122

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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