Clinical trial NCT01023373: Revascularization of Renal Artery Stenosis Versus Medical Therapy for the Treatment of Ischemic Nephropathy
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atherosclerosis
Chronic Kidney Disease
Hypertension, Renovascular
Ischemic Nephropathy
Renal Artery Stenosis
Keywords: 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
Lead sponsor: Azienda Unita Sanitaria Locale di Piacenza
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: 0.5, 1 and 2 years follow up plus extended 4 yrs
Secondary outcomes:
measure: Systolic and diastolic blood pressure values at 0.5, 1 and 2 yrs follow up, with an extended follow up after 2 yrs
timeFrame: 0.5, 1 and 2 years follow up plus extended 4 yrs
measure: Number of hypotensive drugs
timeFrame: 0.5, 1 and 2 years follow up plus extended 4 yrs
measure: Results of renal scintigraphy
timeFrame: 0.5, 1 and 2 years follow up plus extended 4 yrs
measure: Incidence of complications due to interventional manoeuvres
timeFrame: 0.5, 1 and 2 years follow up plus extended 4 yrs
measure: Changes in the incidence of vascular complications in extra-renal districts
timeFrame: 0.5, 1 and 2 years follow up plus extended 4 yrs
Other outcomes:
Locations:
city: Piacenza
country: Italy
facility: Divisione di Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza
Study officials:
affiliation: Divisione Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza, Italy
name: Roberto Scarpioni
role: PRINCIPAL_INVESTIGATOR
affiliation: U.O. Radiologia II "Guglielmo da Saliceto" Hospital, Piacenza
name: Emanuele Michieletti
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.