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

NCT01023373 | Unknown Phase 4 DMC

• 1 other identifier: 388-2002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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)

  0.5, 1 and 2 years follow up plus extended 4 yrs

Secondary Outcomes (5)

• Systolic and diastolic blood pressure values at 0.5, 1 and 2 yrs follow up, with an extended follow up after 2 yrs

  0.5, 1 and 2 years follow up plus extended 4 yrs

• Number of hypotensive drugs

  0.5, 1 and 2 years follow up plus extended 4 yrs

• Results of renal scintigraphy

  0.5, 1 and 2 years follow up plus extended 4 yrs

• Incidence of complications due to interventional manoeuvres

  0.5, 1 and 2 years follow up plus extended 4 yrs

• Changes in the incidence of vascular complications in extra-renal districts

  0.5, 1 and 2 years follow up plus extended 4 yrs

Study Arms (2)

B:PTRS

EXPERIMENTAL

B: the same medical therapy, as previously described in group A, associated with PTRS

Procedure: PTRS; Device: renal artery stent

A:medical therapy

ACTIVE COMPARATOR

hypotensive drugs, statins and antiplatelet therapy

Drug: Medical treatment; Device: renal artery stent

Interventions

Medical treatment DRUG

hypotensive drugs, statins and anti-platelets

A:medical therapy

PTRS PROCEDURE

Percutaneous transluminal renal artery stenting. The same medical therapy, as in group A, plus PTRS

B:PTRS

renal artery stent DEVICE

Non-drug intervention, percutaneous transluminal renal artery stent angioplasty

B:PTRS

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead

Study Sites (1)

Divisione di Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza

Piacenza, Piacenza, 29100, Italy

Location

Related Publications (1)

• 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.

  PMID: 16245247 RESULT

MeSH Terms

Conditions

Atherosclerosis; Renal Insufficiency, Chronic; Hypertension, Renovascular; Renal Artery Obstruction; Kidney Failure, Chronic; Kidney Diseases; Hypertension; Renal Insufficiency; Vascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Renal

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: October 1, 2003
• Primary Completion: September 1, 2008
• Study Completion: May 1, 2009
• Last Updated: December 2, 2009

Record last verified: 2009-12

Locations

IT (1)