A Phase 4 interventional study of Percutaneous renal denervation and TMNS and Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin in Diabetic Nephropathy and Persistent Proteinuria With Type II Diabetes, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-06-01.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 25 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
Procedure: Percutaneous renal denervation and TMNS
Patients 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 treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
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)
proteinuria/creatininuria ratio
Time frame: from baseline to 1 year
Number of patients with a decrease of the PU/CrU >50% ratio
Time frame: from baseline to 1 year
Evaluation of the slope of decay of the PU/CrU
Time frame: from baseline to 1 year
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
Time frame: from baseline to 1 year
Outcome of the GFR assessed by 51Cr-EDTA clearance
Only in the experimental arm
Time frame: from randomisation to 1 year
Decrease of the blood pressure assessed on ABPM
Time frame: From randomisation to 1 year
Anti-hypertensive regimen score
Time frame: 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 \<
Time frame: 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
Time frame: from baseline to 1 year
Evaluate the outcome of biological parameters
eGFR (MDRD formula), proteinuria/creatininuria ratio
Time frame: 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
Time frame: 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
Time frame: from randomisation to 1 year
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris