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The Impact of Statin Holiday in Dialysis Patients Over 70 Years Old on Mental Function, Physical Function and Frailty

Phase 4
Waitlist Available
Led By Julia Schneider
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in mobility at 12 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

Patients who are on chronic dialysis and 70 and older are frequently on multiple medications including statins. However, the benefit of statins in dialysis patient population is uncertain. Several randomized trials showed no benefit of statins on mortality in dialysis patient population. Guidelines recommend not starting statins in patients on dialysis who are not already taking them. However, there are no guidelines on what to do in patients who are already taking statins. The investigators are doing a short pilot study to discontinue statin in our dialysis patient population and evaluating the effects on discontinuation of statins on quality of life, cognition, as physical strength.

Eligible Conditions
  • Renal Disease
  • Sleep Apnea and Cardiovascular Disease
  • Cardiovascular Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in frailty at 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in frailty at 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in quality of life
Secondary study objectives
Change in handgrip strength
Other study objectives
Change in cognition
Change in frailty
Change in mobility

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Discontinue statinExperimental Treatment1 Intervention
Patients randomized to this group will stop using the statins they are currently prescribed and will not use their statin medication for 12 weeks.
Group II: Usual careActive Control1 Intervention
These patients will continue as statins as usual.

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Who is running the clinical trial?

Loyola UniversityLead Sponsor
160 Previous Clinical Trials
31,426 Total Patients Enrolled
Julia SchneiderPrincipal InvestigatorLoyola University Chicago
~4 spots leftby Jan 2026
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