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Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

Study acronym: Senergy-CKD
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Jul 30, 2026 to Dec 31, 2026
    v10
  2. Eligibility criteria expanded, about 56 wordsv9
  3. Site contacts updated at 1 of 2 sitesv8
  4. Eligibility criteria expanded, about 11 wordsv7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Jun 1, 2023 to Sep 8, 2023
    • Collaborators: 1 to 2
    v5
  2. Start date: Apr 1, 2023 to Jun 1, 2023v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 7 more changesShow less
    • Start date: Jul 15, 2022 to Apr 1, 2023
    • Enrollment target: 102 to 80
    • Interventions: Veverimer (Drug), placebo (Drug) to Sodium bicarbonate (Drug), placebo (Drug)
    • Eligibility criteria revised
    • Study description shortened, about 25 words
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 1 word
  4. Start date: Dec 1, 2021 to Jul 15, 2022v2 Show 7 more changesShow less
    • Study sites: 0 to 2
    • Interventions: Sodium bicarbonate (Drug), Sodium bicarbonate placebo (Drug), Veverimer (Drug), Veverimer placebo (Drug) to Veverimer (Drug), placebo (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description shortened, about 12 words
    • Study title shortened, about 7 words
    • Study arms: 4 to 2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Skeletal muscle metabolic health is critical for mobility and an underrecognized target of metabolic acidosis in chronic kidney disease. Impaired muscle mitochondrial metabolism underlies poor physical endurance increasing the risk of mobility disability. The proposed project will use precise in vivo tools to study the pathophysiology of poor physical endurance in a clinical trial treating metabolic acidosis among persons living with chronic kidney disease.
Trial Details
NCT Number NCT04984226
Lead Sponsor University of California, Davis
Collaborators: Vanderbilt University Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Chronic Kidney Diseases, Metabolic Acidosis, Fatigue, Physical Endurance, Insulin Resistance, Mitochondrial Energetics, Diabetes
Related terms Acidosis, Diabetes Mellitus, Fatigue, Insulin Resistance, Renal Insufficiency, Chronic
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov