Bicarbonate Administration in CKD

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

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

Acidosis
Chronic Kidney Disease

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

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

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