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Renal Denervation in Diabetic Nephropathy (DERENEDIAB)

This study is currently recruiting participants. (see Contacts and Locations)
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

April 18, 2012
June 5, 2013
April 2012
April 2015   (final data collection date for primary outcome measure)
proteinuria/creatininuria ratio [ Time Frame: from baseline to 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01588795 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Renal Denervation in Diabetic Nephropathy
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetic Nephropathy
  • Persistent Proteinuria With Type II Diabetes
  • 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)
  • 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
Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
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
France
 
NCT01588795
P110122
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Guillaume Bobrie, MD HTA department
Assistance Publique - Hôpitaux de Paris
June 2013

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