Diabetic NephropathyPhase 4DERENEDIABNCT01588795
Renal Denervation in Diabetic Nephropathy
A Phase 4 study testing Percutaneous renal denervation and TMNS and Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin in people with Diabetic Nephropathy and Persistent Proteinuria With Type II Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathy, Persistent Proteinuria With Type II Diabetes
- What is being tested?
- Percutaneous renal denervation and TMNS and Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Percutaneous renal denervation and TMNS, Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin
- Keywords
- Diabetic nephropathy, renal denervation, nephroprotection, Renal failure, Renal injury, End stage renal disease
- Medical subject headings
- Diabetic Nephropathies, Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous renal denervation and TMNSProcedure or surgery
Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statinDrug
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 group | Role | What they receive |
|---|---|---|
| Denervation + TMNS | Experimental | Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications Receives: Procedure: Percutaneous renal denervation and TMNS |
| TMNS | Active comparator | Patients are maintained on standardized anti-proteinuric medications Receives: Drug: Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
proteinuria/creatininuria ratio
Measured: from baseline to 1 year
Secondary outcomes (11)
Number of patients with a decrease of the PU/CrU >50% ratio
Measured: from baseline to 1 year
Evaluation of the slope of decay of the PU/CrU
Measured: 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
Measured: from baseline to 1 year
Outcome of the GFR assessed by 51Cr-EDTA clearance
Only in the experimental arm
Measured: from randomisation to 1 year
Decrease of the blood pressure assessed on ABPM
Measured: From randomisation to 1 year
Anti-hypertensive regimen score
Measured: 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 <
Measured: 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
Measured: from baseline to 1 year
Evaluate the outcome of biological parameters
eGFR (MDRD formula), proteinuria/creatininuria ratio
Measured: 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
Measured: 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
Measured: from randomisation to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Bobrie, MD, Principal investigator, HTA department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588795
- Sponsor's protocol ID
- P110122
- Acronym
- DERENEDIAB
- Status last verified
- May 2016
- First submitted
- 18 Apr 2012
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25186534
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation in Patients With Diabetic Nephropathy and Persistent Proteinuria
- ClinicalTrials.gov ID
- NCT01588795
- Acronym / sponsor ID
- DERENEDIAB / P110122
- Keywords
- Diabetic nephropathy, renal denervation, nephroprotection, Renal failure, Renal injury, End stage renal disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denervation + TMNS | Experimental | Procedure: Percutaneous renal denervation and TMNSPatients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications |
| TMNS | Active comparator | Drug: Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statinPatients are maintained on standardized anti-proteinuric medications |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous renal denervation and TMNSPatients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications | Procedure or surgery | Denervation + TMNS |
| Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statinPatients 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) | Drug | TMNS |
Primary outcome
proteinuria/creatininuria ratio
Time frame: from baseline to 1 year
11 secondary outcomes
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
Time frame: from baseline to 1 year
Outcome of the GFR assessed by 51Cr-EDTA clearance
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
Time frame: from baseline to 1 year
Evaluation of safety and tolerance of renal denervation in diabetic patients with overt proteinuria
Time frame: from baseline to 1 year
Evaluate the outcome of biological parameters
Time frame: from baseline to 1 year
Evaluate the diabetic neuropathy/dysautonomy
Time frame: from randomisation to 1 year
Evaluate the outcome of specific kidney injury markers
Time frame: from randomisation to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Derived from this study: PubMed 25186534Persu 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.
Related trials for Diabetic Nephropathy
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
RecruitingPhase 2
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Diabetic Kidney Disease (DKD)
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Not yet recruitingObservational study
Impact of AI-Based Breath Ammonia Kidney Function Results on Clinical Pharmacist Medication Recommendations
Diabetes Mellitus, Type 2, Diabetic Nephropathies
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Bobrie, MD principal investigator
HTA department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous renal denervation and TMNS and Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin in people with Diabetic Nephropathy and Persistent Proteinuria With Type II Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proteinuria/creatininuria ratio (time frame: from baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01588795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016; AzTrials last refreshed its copy on 2 Nov 2026.