Revascularization of Renal Artery Stenosis Versus Medical Therapy for the Treatment of Ischemic Nephropathy
NCT ID: NCT01023373
Last Updated: 2009-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2003-10-31
2009-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
B:PTRS
B: the same medical therapy, as previously described in group A, associated with PTRS
PTRS
Percutaneous transluminal renal artery stenting. The same medical therapy, as in group A, plus PTRS
renal artery stent
Non-drug intervention, percutaneous transluminal renal artery stent angioplasty
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
A:medical therapy
hypotensive drugs, statins and antiplatelet therapy
Medical treatment
hypotensive drugs, statins and anti-platelets
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Medical treatment
hypotensive drugs, statins and anti-platelets
PTRS
Percutaneous transluminal renal artery stenting. The same medical therapy, as in group A, plus PTRS
renal artery stent
Non-drug intervention, percutaneous transluminal renal artery stent angioplasty
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
45 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Azienda Unita Sanitaria Locale di Piacenza
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Divisione Nefrologia e Dialisi, da Saliceto Hospital, AUSL Piacenza, Italy
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roberto Scarpioni
Role: PRINCIPAL_INVESTIGATOR
Divisione Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza, Italy
Emanuele Michieletti
Role: PRINCIPAL_INVESTIGATOR
U.O. Radiologia II "Guglielmo da Saliceto" Hospital, Piacenza
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Divisione di Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza
Piacenza, Piacenza, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
388-2002
Identifier Type: -
Identifier Source: org_study_id