- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01588795
Renal Denervation in Diabetic Nephropathy (DERENEDIAB)
May 30, 2016 updated by: 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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75015
- CIC Hopital europeen george pompidou
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Denervation + TMNS
Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
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Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
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Active Comparator: TMNS
Patients are maintained on standardized anti-proteinuric medications
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
proteinuria/creatininuria ratio
Time Frame: from baseline to 1 year
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from baseline to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with a decrease of the PU/CrU >50% ratio
Time Frame: from baseline to 1 year
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from baseline to 1 year
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Evaluation of the slope of decay of the PU/CrU
Time Frame: from baseline to 1 year
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from baseline to 1 year
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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
Time Frame: from baseline to 1 year
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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
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from baseline to 1 year
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Outcome of the GFR assessed by 51Cr-EDTA clearance
Time Frame: from randomisation to 1 year
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Only in the experimental arm
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from randomisation to 1 year
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Decrease of the blood pressure assessed on ABPM
Time Frame: From randomisation to 1 year
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From randomisation to 1 year
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Anti-hypertensive regimen score
Time Frame: from baseline to 1 year
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from baseline to 1 year
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Evaluation of the renal arterial anatomy
Time Frame: from baseline to 1 year
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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 <
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from baseline to 1 year
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Evaluation of safety and tolerance of renal denervation in diabetic patients with overt proteinuria
Time Frame: from baseline to 1 year
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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
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from baseline to 1 year
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Evaluate the outcome of biological parameters
Time Frame: from baseline to 1 year
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eGFR (MDRD formula), proteinuria/creatininuria ratio
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from baseline to 1 year
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Evaluate the diabetic neuropathy/dysautonomy
Time Frame: from randomisation to 1 year
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in the experimental:blood pressure in orthostatism, pulse wave velocimetry, RR interval on the Holter ECG, cutaneous baroreflex
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from randomisation to 1 year
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Evaluate the outcome of specific kidney injury markers
Time Frame: from randomisation to 1 year
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in the experimental group:urinary levels of KIM1 and NGAL before and 1 year after the denervation
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from randomisation to 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Guillaume Bobrie, MD, HTA department
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
April 18, 2012
First Submitted That Met QC Criteria
April 27, 2012
First Posted (Estimate)
May 1, 2012
Study Record Updates
Last Update Posted (Estimate)
June 1, 2016
Last Update Submitted That Met QC Criteria
May 30, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Urologic Diseases
- Urological Manifestations
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Urination Disorders
- Diabetes Mellitus, Type 2
- Kidney Diseases
- Diabetic Nephropathies
- Proteinuria
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Diuretics
- Angiotensin Receptor Antagonists
Other Study ID Numbers
- P110122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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