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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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

Sponsor: Azienda Unità Sanitaria Locale di Piacenza

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Azienda Unità Sanitaria Locale di Piacenza

Dates:
Date Received: December 1, 2009
Date Started: October 2003
Date Completion: May 2009
Last Updated: December 1, 2009
Last Verified: December 2009