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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

Tracking Information
First Submitted Date  ICMJE December 1, 2009
First Posted Date  ICMJE December 2, 2009
Last Update Posted Date December 2, 2009
Study Start Date  ICMJE October 2003
Estimated Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
  • 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 ]
  • Number of hypotensive drugs [ Time Frame: 0.5, 1 and 2 years follow up plus extended 4 yrs ]
  • Results of renal scintigraphy [ Time Frame: 0.5, 1 and 2 years follow up plus extended 4 yrs ]
  • Incidence of complications due to interventional manoeuvres [ Time Frame: 0.5, 1 and 2 years follow up plus extended 4 yrs ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Revascularization of Renal Artery Stenosis Versus Medical Therapy for the Treatment of Ischemic Nephropathy
Official Title  ICMJE Phase 4 Study of Medical Therapy Versus Medical Therapy Plus Renal Artery Stenting in Preventing the Progression of Renal Failure in Atherosclerotic Renovascular Disease
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atherosclerosis
  • Chronic Kidney Disease
  • Hypertension, Renovascular
  • Ischemic Nephropathy
  • Renal Artery Stenosis
Intervention  ICMJE
  • Drug: Medical treatment
    hypotensive drugs, statins and anti-platelets
  • 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
Study Arms  ICMJE
  • Experimental: B:PTRS
    B: the same medical therapy, as previously described in group A, associated with PTRS
    Interventions:
    • Procedure: PTRS
    • Device: renal artery stent
    • Device: renal artery stent
  • Active Comparator: A:medical therapy
    hypotensive drugs, statins and antiplatelet therapy
    Interventions:
    • Drug: Medical treatment
    • Device: renal artery stent
Publications * Scarpioni R, Michieletti E, Cristinelli L, Ugolotti U, Scolari F, Venturelli C, Cancarini G, Pecchini P, Malberti F, Maroldi R, Rozzi G, Olivetti L. Atherosclerotic renovascular disease: medical therapy versus medical therapy plus renal artery stenting in preventing renal failure progression: the rationale and study design of a prospective, multicenter and randomized trial (NITER). J Nephrol. 2005 Jul-Aug;18(4):423-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2009
Estimated Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01023373
Other Study ID Numbers  ICMJE 388-2002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roberto Scarpioni, MD, Divisione Nefrologia e Dialisi, da Saliceto Hospital, AUSL Piacenza, Italy
Study Sponsor  ICMJE Azienda Unità Sanitaria Locale di Piacenza
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Azienda Unità Sanitaria Locale di Piacenza
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP