Atorvastatin Reduces Chronic Inflammation and aVerage Epogen Dose (ARChIVED)

• Status: Withdrawn
• Trial end date: 2017-03-22
• Target enrollment: 0
• Participant gender: All

Summary

The specific aim of this trial is to determine whether initiating moderate- or high-intensity atorvastatin therapy in hemodialysis patient not previously on a statin reduces inflammation and lowers average Epogen utilization. Statin naive patients on maintenance HD will be started on 20mg atorvastatin daily for weeks and then titrated up to 40mg atorvastatin daily for an additional 12 weeks. Patient's inflammatory markers (ferritin, CRP) and weekly Epogen usage will be monitored.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein Healthcare Network
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Stable on Hemoglobin levels on Epogen therapy (Hgb between 9.5-11.5 for prior 3 weeks)

• No statin usage during the prior 3 months

• Complaint with hemodialysis and medications

Exclusion Criteria:

• Prior history of myocardial infarction, stroke or vascular disease

• Prior hospitalization within the past 15 days

• Prior episodes of significant bleeding (trauma, GI bleed, GU bleed, menorrhagia) in the prior 15 days

• Liver disease

• Active malignancy

• Hematologic disorder