Stenting in Renal Dysfunction Caused by Atherosclerotic Renal Artery Stenosis

NCT00150943 | Completed Phase 3

• 2 other identifiers: C99.1810-STARC99.1810
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function and is one of the most important causes of renal failure in the elderly. Current treatment includes restoration of the renal arterial lumen by endovascular stent placement. However, this treatment only affects damage caused by ARAS due to the stenosis and ensuing post-stenotic ischemia. ARAS patients have severe general vascular disease. Atherosclerosis and hypertension can also damage the kidney parenchyma causing renal failure. Medical treatment focuses on the latter. Lipidlowering drugs (statins) could reduce renal failure progression and could reduce the overall high cardiovascular risk. The additional effect on preserving renal function of stent placement as compared to medical therapy alone is unknown. Therefore, the STAR-study aims to compare the effects of renal artery stent placement together with medication vs. medication alone on renal function in ARAS patients. Method: Patients with an ARAS of ≥50% and renal failure (creatinine (Cr) clearance \<80 mL/min/1.73 m2) are randomly assigned to stent placement with medication or to medication alone. Medication consists of statins, anti-hypertensive drugs and antiplatelet therapy. Patients are followed for 2 yrs with extended follow-up to 5 yrs. The primary outcome of this study is a reduction in Cr clearance \>20% compared to baseline. This trial will include 140 patients.

Conditions

Renal Artery Obstruction; Kidney Failure

Keywords

Renal artery stenosis; Stent; Renal failure; Atorvastatin; Hypertension; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Progressive renal function loss (= reduction in estimated Cr clearance by >20%) after 2 yrs follow-up, with an extended follow-up of 5 yrs

Secondary Outcomes (11)

• Acute complications

• Late complications

• Occlusion of the stenotic renal artery

• Incidence and time to doubling of serum Cr

• Initiation of dialysis therapy

Interventions

Renal artery stent DEVICE

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• Ostial atherosclerotic renal artery stenosis ≥50% on CTA, MRA or intra-arterial angiography
• Estimated creatinine clearance \<80 ml/min/1.73m2 according to the Cockcroft and Gault formula, on two occasions within one month

You may not qualify if:

• Declined informed consent
• Proven cholesterol embolisation at previous interventions
• Renal artery diameter \<4mm
• Estimated creatinine-clearance \<15ml/min/1.73m2
• Diabetes Mellitus with proteinuria \>3g/24h
• Any known cause of renal failure other than ischemic nephropathy
• Pulmonary oedema in the presence of bilateral renovascular disease in combination with intolerance of ACE-inhibitors/ Angiotensin-II antagonists defined as a fall of estimated creatinine clearance of \>20%
• Malignant hypertension (fundus grade III/IV)
• Contra-indication for the use of atorvastatin

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (2)

• Bax L, Mali WP, Buskens E, Koomans HA, Beutler JJ, Braam B, Beek FJ, Rabelink TJ, Postma CT, Huysmans FT, Deinum J, Thien T, Schultze Kool LJ, Woittiez AJ, Kouwenberg JJ, van den Meiracker AH, Pattynama PM, van de Ven PJ, Vroegindeweij D, Doorenbos CJ, Aarts JC, Kroon AA, de Leeuw PW, de Haan MW, van Engelshoven JM, Rutten MJ, van Montfrans GA, Reekers JA, Plouin PF, La Batide Alanore A, Azizi M, Raynaud A, Harden PN, Cowling M; STAR Study Group. The benefit of STent placement and blood pressure and lipid-lowering for the prevention of progression of renal dysfunction caused by Atherosclerotic ostial stenosis of the Renal artery. The STAR-study: rationale and study design. J Nephrol. 2003 Nov-Dec;16(6):807-12.

  PMID: 14736007 BACKGROUND

• Bax L, Woittiez AJ, Kouwenberg HJ, Mali WP, Buskens E, Beek FJ, Braam B, Huysmans FT, Schultze Kool LJ, Rutten MJ, Doorenbos CJ, Aarts JC, Rabelink TJ, Plouin PF, Raynaud A, van Montfrans GA, Reekers JA, van den Meiracker AH, Pattynama PM, van de Ven PJ, Vroegindeweij D, Kroon AA, de Haan MW, Postma CT, Beutler JJ. Stent placement in patients with atherosclerotic renal artery stenosis and impaired renal function: a randomized trial. Ann Intern Med. 2009 Jun 16;150(12):840-8, W150-1. doi: 10.7326/0003-4819-150-12-200906160-00119. Epub 2009 May 4.

  PMID: 19414832 DERIVED

MeSH Terms

Conditions

Renal Artery Obstruction; Renal Insufficiency; Hypertension; Atherosclerosis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis

Study Officials

• Jaap J. Beutler, MD.PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: June 1, 2000
• Last Updated: April 27, 2006

Record last verified: 2006-04

Locations

NL (1)