Atorvastatin Reduces Chronic Inflammation and aVerage Epogen Dose (ARChIVED) (ARChIVED)

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.

Study Overview

• Status: Withdrawn
• Conditions: Complication of Renal Dialysis
• Intervention / Treatment: Drug: Atorvastatin

Detailed Description

Patients will be identified and consented. After informed consent is obtained, baseline demographic information, past medical history, dialysis specific information, and laboratory metrics (lipid profile, inflammatory markers) will be obtained from the electronic medical records. For the first 12 weeks, all subjects will be instructed to take one 20mg atorvastatin tablet daily; atorvastatin tablets will be dispensed by the research team in 30-tablet increments every month to ensure compliance and prevent diversion. Subjects will undergo standard-of-care hemodialysis with routine hemoglobin monitoring and Epogen titration according to the dialysis center protocol. Every two weeks, they will be assessed by a research coordinator who will monitor for medication adverse effects (see attached patient survey) and medication compliance (pill counts) at alternating visits. After 12 weeks, lipid profile and inflammatory markers will be rechecked or obtained from the electronic medical record. For the subsequent 12 weeks (ie. weeks 12-24), subjects will be instructed to take two 20mg atorvastatin tablets (40mg total) daily. If the subject is unable to tolerate 40mg of atorvastatin daily due to medication adverse effects, they will continue to take 20mg atorvastatin daily for the remainder of the trial. Epogen will be titrated and subjects will be monitored as above. At the completion of the study, a lipid panel and inflammatory markers will be checked for a third time. Epogen usage and dialysis specific information will be recorded continuously throughout the study.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: atorvastatin; Patients in this arm will receive 20mg atorvastatin PO daily for 12 weeks followed by 40mg atorvastatin PO daily for 12 weeks.	Drug: Atorvastatin; Patients will be given 20mg atorvastatin daily for 12 weeks and then increased to 40mg atorvastatin daily for an additional 12 weeks.; Other Names: Statin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epoetin alfa (Epogen) utilization measured in units per week	The amount of epoetin alfa, measured in units, needed to maintain a patient's hemoglobin between 11.0 and 12.0 gm/dL	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
C-reactive protein, ferritin levels	24 weeks
Total cholesterol level, LDL level, HDL level	24 weeks

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2016
• Primary Completion (Actual): March 22, 2017
• Study Completion (Actual): March 22, 2017

Study Registration Dates

• First Submitted: March 18, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 4802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No