Clincosm LogoSign in Get a demo

Atorvastatin Reduces Chronic Inflammation and aVerage Epogen Dose (ARChIVED)

Sponsor
Albert Einstein Healthcare Network (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02764736
Collaborator
(none)
0
Enrollment
1
Arm
12.6
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Open label study
Primary Purpose:
Treatment
Official Title:
Atorvastatin Reduces Chronic Inflammation and aVerage Epogen Dose (ARChIVED)
Actual Study Start Date :
Mar 4, 2016
Actual Primary Completion Date :
Mar 22, 2017
Actual Study Completion Date :
Mar 22, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Epoetin alfa (Epogen) utilization measured in units per week [24 weeks]

      The amount of epoetin alfa, measured in units, needed to maintain a patient's hemoglobin between 11.0 and 12.0 gm/dL

    Secondary Outcome Measures

    1. C-reactive protein, ferritin levels [24 weeks]

    2. Total cholesterol level, LDL level, HDL level [24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Albert Einstein Healthcare Network

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pradhum Ram, Principal investigator, Albert Einstein Healthcare Network
    ClinicalTrials.gov Identifier:
    NCT02764736
    Other Study ID Numbers:
    • 4802
    First Posted:
    May 6, 2016
    Last Update Posted:
    May 18, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Inflammation
    Atorvastatin

    Study Results

    No Results Posted as of May 18, 2017