Trial Outcomes & Findings for Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease (NCT NCT02031770)

Results Overview

The primary endpoint is change in brachial artery FMD between treatment and control conditions. Each treatment period is 6 weeks in duration with a 2 week washout period in between. Outcome measures will be repeated at the beginning and end of each period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

6 weeks and 12 weeks

Results posted on

2020-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	A: Treatment/Control Patients will start with sodium bicarbonate treatment then switch to control (no treatment) Sodium bicarbonate: Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L. Control: subjects will receive no treatment	B: Control/Treatment Patients will start with control (no treatment) then switch to sodium bicarbonate treatment Sodium bicarbonate: Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L. Control: subjects will receive no treatment
Overall Study STARTED	10	10
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Participants n=20 Participants Patients will start with sodium bicarbonate treatment then switch to control (no treatment) Sodium bicarbonate: Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L. Control: subjects will receive no treatment
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 weeks and 12 weeks

The primary endpoint is change in brachial artery FMD between treatment and control conditions. Each treatment period is 6 weeks in duration with a 2 week washout period in between. Outcome measures will be repeated at the beginning and end of each period.

Outcome measures

Outcome measures
Measure	Treatment n=20 Participants	Control n=20 Participants
Change in Brachial Artery Flow Mediated Dilation (FMD)	1.1 absolute change in percent FMD Standard Deviation 2.6	-0.7 absolute change in percent FMD Standard Deviation 1.9

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=20 participants at risk	Control n=20 participants at risk
Gastrointestinal disorders Nausea	35.0% 7/20 • Number of events 7	0.00% 0/20
Cardiac disorders Leg swelling	20.0% 4/20 • Number of events 4	0.00% 0/20

Additional Information

Dr. Jessica Kendrick

University of Colorado Denver

Phone: 3037244837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place