Renal Denervation in Diabetic Nephropathy

NCT ID: NCT01588795

Last Updated: 2016-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-01-31

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.

Conditions

Diabetic Nephropathy; Persistent Proteinuria With Type II Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Denervation + TMNS

Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications

Group Type: EXPERIMENTAL

Percutaneous renal denervation and TMNS

Intervention Type: PROCEDURE

Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications

TMNS

Patients are maintained on standardized anti-proteinuric medications

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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)

Interventions

Percutaneous renal denervation and TMNS

Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications

Intervention Type: PROCEDURE

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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Bobrie, MD

Role: PRINCIPAL_INVESTIGATOR

HTA department

Locations

CIC Hopital europeen george pompidou

Paris, Paris, France

Countries

France

References

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. No abstract available.

Reference Type: DERIVED

PMID: 25186534 (View on PubMed)

Other Identifiers

P110122

Identifier Type: -

Identifier Source: org_study_id