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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

Summary

This trial will test if giving bicarbonate to patients with chronic kidney disease can improve their blood vessel health and reduce heart size. These patients often have low bicarbonate levels, which are linked to higher risks of heart problems. The goal is to see if bicarbonate can help reduce these risks. Bicarbonate supplementation has been shown to slow the progression of chronic kidney disease and improve nutritional status.

Eligible Conditions
  • Chronic Kidney Disease
  • Metabolic Acidosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, 1, 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, 1, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Change in Serum T50
Changes in Aldosterone
Changes in Endothelin-1
+1 more

Trial 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
1,786 Previous Clinical Trials
2,787,499 Total Patients Enrolled
Jessica Kendrick, MDPrincipal InvestigatorUniversity of Colorado, Denver
5 Previous Clinical Trials
275 Total Patients Enrolled
~13 spots leftby Sep 2025
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