Renal Denervation in Diabetic Nephropathy (DERENEDIAB)

This study is currently recruiting participants.

Verified June 2013 by Assistance Publique - Hôpitaux de Paris

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01588795

First received: April 18, 2012

Last updated: June 5, 2013

Last verified: June 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 18, 2012

Last Updated Date

June 5, 2013

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

April 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

proteinuria/creatininuria ratio [ Time Frame: from baseline to 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01588795 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of patients with a decrease of the PU/CrU >50% ratio [ Time Frame: from baseline to 1 year ] [ Designated as safety issue: No ]
Evaluation of the slope of decay of the PU/CrU [ Time Frame: from baseline to 1 year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: from randomisation to 1 year ] [ Designated as safety issue: Yes ]
Only in the experimental arm
Decrease of the blood pressure assessed on ABPM [ Time Frame: From randomisation to 1 year ] [ Designated as safety issue: No ]
Anti-hypertensive regimen score [ Time Frame: from baseline to 1 year ] [ Designated as safety issue: No ]
Evaluation of the renal arterial anatomy [ Time Frame: from baseline to 1 year ] [ Designated as safety issue: Yes ]
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 <
Evaluation of safety and tolerance of renal denervation in diabetic patients with overt proteinuria [ Time Frame: from baseline to 1 year ] [ Designated as safety issue: Yes ]
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
Evaluate the outcome of biological parameters [ Time Frame: from baseline to 1 year ] [ Designated as safety issue: No ]
eGFR (MDRD formula), proteinuria/creatininuria ratio
Evaluate the diabetic neuropathy/dysautonomy [ Time Frame: from randomisation to 1 year ] [ Designated as safety issue: No ]
in the experimental:blood pressure in orthostatism, pulse wave velocimetry, RR interval on the Holter ECG, cutaneous baroreflex
Evaluate the outcome of specific kidney injury markers [ Time Frame: from randomisation to 1 year ] [ Designated as safety issue: Yes ]
in the experimental group:urinary levels of KIM1 and NGAL before and 1 year after the denervation

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Renal Denervation in Diabetic Nephropathy

Official Title ^ICMJE

Renal Denervation in Patients With Diabetic Nephropathy and Persistent Proteinuria

Brief 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.

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetic Nephropathy
Persistent Proteinuria With Type II Diabetes

Intervention ^ICMJE

Procedure: Percutaneous renal denervation and TMNS
Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
Drug: 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)

Study Arm (s)

Experimental: Denervation + TMNS
Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications

Intervention: Procedure: Percutaneous renal denervation and TMNS
Active Comparator: TMNS
Patients are maintained on standardized anti-proteinuric medications

Intervention: Drug: Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

April 2015

Estimated Primary Completion Date

April 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Guillaume Bobrie, MD	+33 1 56 09 37 71	guillaume.bobrie@egp.aphp.fr
Contact: Marc SAPOVAL, PD, PhD	00 33 (1) 56 09 37 40	marc.sapoval2@egp.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01588795

Other Study ID Numbers ^ICMJE

P110122

Has Data Monitoring Committee

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Guillaume Bobrie, MD

HTA department

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

June 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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