Stenting in Renal Dysfunction Caused by Atherosclerotic Renal Artery Stenosis

This study has been completed.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00150943
First received: September 6, 2005
Last updated: April 26, 2006
Last verified: April 2006
  Purpose

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.


Condition Intervention Phase
Renal Artery Obstruction
Kidney Failure
Device: Renal artery stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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 (STAR)

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Acute complications
  • Late complications
  • Occlusion of the stenotic renal artery
  • Incidence and time to doubling of serum Cr
  • Initiation of dialysis therapy
  • Effect on hypertension and the occurrence of therapy refractory or malignant hypertension
  • Incidence of pulmonary edema
  • Cardiovascular morbidity and mortality
  • Total mortality
  • Cost-effectiveness
  • Quality of life

Estimated Enrollment: 140
Study Start Date: June 2000
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Myocardial infarction or CVA <3 months before planned date of inclusion
  • Contra-indication for the use of atorvastatin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150943

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Jaap J. Beutler, MD.PhD UMC Utrecht
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00150943     History of Changes
Other Study ID Numbers: C99.1810-STAR, C99.1810
Study First Received: September 6, 2005
Last Updated: April 26, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Renal artery stenosis
Stent
Renal failure
Atorvastatin
Hypertension
Atherosclerosis

Additional relevant MeSH terms:
Renal Artery Obstruction
Renal Insufficiency
Arterial Occlusive Diseases
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014