Atorvastatin Reduces Chronic Inflammation and aVerage Epogen Dose (ARChIVED)

NCT02764736 | Withdrawn DMC

• 1 other identifier: 4802
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Complication of Renal Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• C-reactive protein, ferritin levels

  24 weeks

• Total cholesterol level, LDL level, HDL level

  24 weeks

Study Arms (1)

atorvastatin

EXPERIMENTAL

Patients in this arm will receive 20mg atorvastatin PO daily for 12 weeks followed by 40mg atorvastatin PO daily for 12 weeks.

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

Patients will be given 20mg atorvastatin daily for 12 weeks and then increased to 40mg atorvastatin daily for an additional 12 weeks.

Also known as: Statin

atorvastatin

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

MeSH Terms

Interventions

Atorvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open label study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: May 6, 2016
• Study Start: March 4, 2016
• Primary Completion: March 22, 2017
• Study Completion: March 22, 2017
• Last Updated: May 18, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share