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Revascularization of Renal Artery Stenosis Versus Medical Therapy for the Treatment of Ischemic Nephropathy (NITER)

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ClinicalTrials.gov Identifier: NCT01023373
Recruitment Status : Unknown
Verified December 2009 by Azienda Unità Sanitaria Locale di Piacenza.
Recruitment status was:  Active, not recruiting
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Sponsor:
Information provided by:
Azienda Unità Sanitaria Locale di Piacenza

Brief Summary:
The aim of the study is to value, in patients with chronic kidney disease and hypertension, whether medical therapy plus interventional renal artery revascularization is superior to medical therapy alone for the treatment of hemodynamically significant (>70%) atherosclerotic renal artery stenosis, diagnosed by duplex doppler ultrasonography and confirmed by magnetic resonance angiography, in terms of avoidance of the progression of renal damage, control of hypertension and in reducing the cerebro and cardiovascular complications.

Condition or disease Intervention/treatment Phase
Atherosclerosis Chronic Kidney Disease Hypertension, Renovascular Ischemic Nephropathy Renal Artery Stenosis Drug: Medical treatment Procedure: PTRS Device: renal artery stent Phase 4

Detailed Description:

Atherosclerotic renovascular disease (ARVD), due to renal hypoperfusion caused by mono or bilateral renal artery stenosis (RAS), is a increasing cause of chronic kidney disease and many elderly patients start dialysis due to ARDVD. Moreover ARVD is frequently progressive and reduces life-expectancy more than other causes of end stage renal disease, with a mortality rate higher than in patients with stable angina, similar to that of patients operated for colon cancer.

Unfortunately, there is not a definite therapy to cure this disease, despite important advancements in both medical therapy and in interventional radiology. Aim of the study is to see whether percutaneous transluminal interventional radiology plus stenting (PTRS) of the renal artery offers more, in terms of both preventing the progression of renal failure and controlling the hypertension, compared with the medical therapy addressed to control hypertension, improve the dyslipidemic profile and optimise the platelet anti-aggregant therapy, following the most recent guidelines. The eligible patients will be centrally randomized to:

  1. medical treatment with hypotensive drugs (all class of hypotensive agents will be used according to single-center experience including drugs agent on renin-angiotensin-aldosterone-system, when permitted), lipid lowering therapy (namely all class of statins-or hydroxymethylglutaryl-coA reductase inhibitors)and anti-platelet (acetylsalicylate and/or ticlopidine or clopidrogel according to single-center experience) or to
  2. the same medical therapy, as previously described in group a, associated with PTRS, according to a standardized protocol, with a follow up at 2 years extended to other 2 years

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Medical Therapy Versus Medical Therapy Plus Renal Artery Stenting in Preventing the Progression of Renal Failure in Atherosclerotic Renovascular Disease
Study Start Date : October 2003
Estimated Primary Completion Date : September 2008
Estimated Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: B:PTRS
B: the same medical therapy, as previously described in group A, associated with PTRS
Procedure: PTRS
Percutaneous transluminal renal artery stenting. The same medical therapy, as in group A, plus PTRS

Device: renal artery stent
Non-drug intervention, percutaneous transluminal renal artery stent angioplasty

Device: renal artery stent
Adding the renal artery stenting (in group B) to the optimal medical therapy (as in group A) that includes hypotensive drugs, statins and antiplatelet therapy

Active Comparator: A:medical therapy
hypotensive drugs, statins and antiplatelet therapy
Drug: Medical treatment
hypotensive drugs, statins and anti-platelets

Device: renal artery stent
Adding the renal artery stenting (in group B) to the optimal medical therapy (as in group A) that includes hypotensive drugs, statins and antiplatelet therapy




Primary Outcome Measures :
  1. Death, Initiation of dialysis therapy or either serum creatinine increase more than 20% or reduction by > 20% in estimated clearance of creatinine (with MDRD formula) [ Time Frame: 0.5, 1 and 2 years follow up plus extended 4 yrs ]

Secondary Outcome Measures :
  1. Systolic and diastolic blood pressure values at 0.5, 1 and 2 yrs follow up, with an extended follow up after 2 yrs [ Time Frame: 0.5, 1 and 2 years follow up plus extended 4 yrs ]
  2. Number of hypotensive drugs [ Time Frame: 0.5, 1 and 2 years follow up plus extended 4 yrs ]
  3. Results of renal scintigraphy [ Time Frame: 0.5, 1 and 2 years follow up plus extended 4 yrs ]
  4. Incidence of complications due to interventional manoeuvres [ Time Frame: 0.5, 1 and 2 years follow up plus extended 4 yrs ]
  5. Changes in the incidence of vascular complications in extra-renal districts [ Time Frame: 0.5, 1 and 2 years follow up plus extended 4 yrs ]


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≤ 80 years
  • Presence of ostial renal artery stenosis ≥ 70% (determined by Duplex Doppler ultrasonography and confirmed by Magnetic Resonance valuated by at least two experienced operators)
  • Serum creatinine ≤ 3 mg/dl and/or creatinine clearance (Modification of Diet in Renal Disease, MDRD formula)≥ 30 ml/min, defined as stage 3 or greater CKD based on National Kidney Foundation classification
  • Longitudinal ultrasonographic diameter of the stenotic kidney ≥ 8 cm
  • Blood pressure values ≤ 150/90 mmHg with the use of less than four hypotensives drugs

Exclusion Criteria:

  • Age > 80 years
  • Other well-known nephropathy cause of renal failure
  • Duplex doppler ultrasonography Resistive Index values >0.8
  • Total occlusion of renal artery lumen
  • Occurrence of cerebral or cardiac vascular diseases in the 6 months before the enrolment in the study
  • Malignancy with a life expectation less than one year
  • Previous documented cholesterol thrombo embolization episodes (clinically, bioptically or instrumentally)
  • Liver failure
  • Cardiac failure (NYHA IV class) or instable angina
  • Well-known intolerance or contraindications to the use of iodinated contrast media, to statins or to anti platelets drugs
  • Previous renal angioplasty
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023373


Locations
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Italy
Divisione di Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza
Piacenza, Italy, 29100
Sponsors and Collaborators
Azienda Unità Sanitaria Locale di Piacenza
Investigators
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Principal Investigator: Roberto Scarpioni Divisione Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza, Italy
Principal Investigator: Emanuele Michieletti U.O. Radiologia II "Guglielmo da Saliceto" Hospital, Piacenza

Publications of Results:
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Responsible Party: Roberto Scarpioni, MD, Divisione Nefrologia e Dialisi, da Saliceto Hospital, AUSL Piacenza, Italy
ClinicalTrials.gov Identifier: NCT01023373     History of Changes
Other Study ID Numbers: 388-2002
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009

Keywords provided by Azienda Unità Sanitaria Locale di Piacenza:
Angioplasty
Atherosclerotic reno vascular disease (ARVD)
Cardio- and cerebro- vascular comorbidity
End stage renal disease (ERSD)
kidney diseases
High blood pressure
Hypertension
Ischemic nephropathy
Percutaneous transluminal renal artery stenting (PTRS)
Randomized controlled trials
Renal artery stenosis (RAS)
Renal insufficiency
Vascular diseases

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Artery Obstruction
Hypertension, Renovascular
Hypertension
Atherosclerosis
Ischemia
Constriction, Pathologic
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Hypertension, Renal
Antihypertensive Agents