Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denervation + TMNS | Experimental | Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications |
|
| TMNS | Active Comparator | Patients are maintained on standardized anti-proteinuric medications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous renal denervation and TMNS | Procedure | Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications |
| Measure | Description | Time Frame |
|---|---|---|
| proteinuria/creatininuria ratio | from baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with a decrease of the PU/CrU >50% ratio | from baseline to 1 year | |
| Evaluation of the slope of decay of the PU/CrU | from baseline to 1 year | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guillaume Bobrie, MD | HTA department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC Hopital europeen george pompidou | Paris | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25186534 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin | 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) |
|
| 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 |
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 | Only in the experimental arm | from randomisation to 1 year |
| Decrease of the blood pressure assessed on ABPM | From randomisation to 1 year |
| Anti-hypertensive regimen score | from baseline to 1 year |
| Evaluation of the renal arterial anatomy | 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 | 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 | eGFR (MDRD formula), proteinuria/creatininuria ratio | from baseline to 1 year |
| Evaluate the diabetic neuropathy/dysautonomy | 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 | in the experimental group:urinary levels of KIM1 and NGAL before and 1 year after the denervation | from randomisation to 1 year |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided