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Alkalinizing Agent
Sodium Bicarbonate for Chronic Kidney Disease
N/A
Waitlist Available
Led By Jessica Kendrick, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, 1, 6 and 12 months
Awards & highlights
Study Summary
This study is evaluating whether bicarbonate may help improve cardiovascular health in individuals with chronic kidney disease.
Eligible Conditions
- Chronic Kidney Disease
- Metabolic Acidosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline, 1, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, 1, 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Aortic Pulse Wave Velocity
Change in Brachial Artery Flow Mediated Dilation
Secondary outcome measures
Change in Left Ventricular Mass Index
Other outcome measures
Change in Serum T50
Changes in Aldosterone
Changes in Endothelin-1
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sodium BicarbonateExperimental Treatment1 Intervention
Participants assigned to oral sodium bicarbonate will receive 0.5 mEq/kg-lean body weight (LBW)/day for the entire 12 months. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Group II: PlaceboPlacebo Group1 Intervention
Subjects randomly assigned to placebo will take the same number of capsules as if they were assigned to receive 0.5 mEq/kg-LBW/day of sodium bicarbonate. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium bicarbonate
2012
Completed Phase 4
~3680
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,439 Total Patients Enrolled
Jessica Kendrick, MDPrincipal InvestigatorUniversity of Colorado, Denver
4 Previous Clinical Trials
215 Total Patients Enrolled
Frequently Asked Questions
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