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NCT05422534 · ClinicalTrials.gov registry record · Phase 3
CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease
A Phase 3 study of End Stage Renal Disease, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
- 2
- Study locations
NCT05422534: Recruiting Phase 3 study of End Stage Renal Disease, sponsored by Vanderbilt University Medical Center.
NCT05422534 is a Phase 3 study of End Stage Renal Disease that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 156 participants, below the 832-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05422534, a Phase 3 study of End Stage Renal Disease, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 156 participants
- Enrollment target
- 2
- Study locations
Study Summary
Frailty and sarcopenia are modifiable risk factors for morbidity and mortality in patients with ESRD. Exercise is the recommended intervention to prevent frailty and sarcopenia, however, many clinical trials have shown limited clinical improvement in muscle mass and physical function. We propose that mitochondrial dysfunction is one of the deterrents to the effectiveness of the exercise. We plan to evaluate the additive effect of HIIT and CoQ10, a mitochondrial-targeted therapy, on mitochondrial function and physical performance. Understanding the interplay among CoQ10, exercise, and mitochondrial function will identify novel mechanisms to improve the efficiency of exercise. This will also serve to prevent frailty, sarcopenia, and muscle dysfunction in patients with ESRD.
Primary Outcome
ERSD 38.7 +/- 5.9 seconds ,with HIIT alone 3.87 sec, with HIIT and CoQ10 11.61.sec
Conditions Studied
Interventions
- DRUG Placebo
- DIETARY_SUPPLEMENT CoQ10
- BEHAVIORAL HB-HIIT
- BEHAVIORAL Observational
Study Locations (2)
California
- University of California Davis Health - Sacramento
Tennessee
- Vanderbilt University Medical Center-GCRC - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2027-10-01 |
| Phase | Phase 3 |
What NCT05422534 shows while recruiting
NCT05422534 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 832-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (81% lower).
The record links to 1 condition, with End Stage Renal Disease appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05422534 reports a single indexed study location in California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05422534 about?
NCT05422534 is a clinical study titled "CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease". Frailty and sarcopenia are modifiable risk factors for morbidity and mortality in patients with ESRD. Exercise is the recommended intervention to prevent frailty and sarcopenia, however, many clinical trials have shown limited clinical improvement in muscle mass and physical function. We propose tha...
What is the current status of trial NCT05422534?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2023-06-01. Estimated completion is 2027-10-01.
What conditions does trial NCT05422534 study?
This clinical trial studies the following conditions: End Stage Renal Disease.
What interventions are being tested in trial NCT05422534?
The interventions under investigation include: Placebo (DRUG), CoQ10 (DIETARY_SUPPLEMENT), HB-HIIT (BEHAVIORAL), Observational (BEHAVIORAL).
Who is sponsoring clinical trial NCT05422534?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05422534 being conducted?
This trial has 2 study locations across California, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05422534's enrollment target sits among peer trials
156 25th of 86 higher than 62 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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