Back to results

Bicarbonate Administration in CKD

Primary Purpose

Chronic Kidney Disease, Metabolic Acidosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sodium bicarbonate

Placebo

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 21 years
Serum bicarbonate 22-25 mEq/L on 2 separate measurements (at least 1 day apart)
CKD stage 3B or 4 at time of screening (eGFR 15-44 ml/min/1.73m2)
Blood pressure <130/80 mm Hg prior to randomization
BMI < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
Able to provide consent
Stable anti-hypertensive regimen for at least one month prior to randomization
Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).

Exclusion Criteria:

Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
Uncontrolled hypertension
Serum potassium < 3.3 or ≥ 5.5 mEq/L at screening
New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
Factors judged to limit adherence to interventions
Anticipated initiation of dialysis or kidney transplantation within 12 months
Current participation in another research study
Pregnancy or planning to become pregnant or currently breastfeeding
Chronic use of supplemental oxygen
Use of immunosuppression in past 3 months
Metal implant or implanted electrical device (patient will be unable to get MRI)

Sites / Locations

University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sodium Bicarbonate

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Brachial Artery Flow Mediated Dilation

Change in Aortic Pulse Wave Velocity

Secondary Outcome Measures

Change in Left Ventricular Mass Index

Full Information

NCT ID

NCT02915601

First Posted

September 23, 2016

Last Updated

June 30, 2023

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT02915601

Brief Title

Bicarbonate Administration in CKD

Official Title

Bicarbonate Administration in CKD

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

January 15, 2017 (Actual)

Primary Completion Date

May 19, 2022 (Actual)

Study Completion Date

May 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Low serum bicarbonate levels, even within the normal laboratory range, are strongly associated with increased risks of hypertension, endothelial dysfunction, cardiovascular disease and death. The current proposal will investigate whether bicarbonate administration in patients with chronic kidney disease (CKD) will improve the health and function of arteries and reduce the size of the left ventricle of the heart. Overall, the proposed research will provide important new scientific evidence upon which physicians can base recommendations to patients with CKD to decrease the risk of developing cardiovascular diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, Metabolic Acidosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

109 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sodium Bicarbonate

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sodium bicarbonate

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in Brachial Artery Flow Mediated Dilation

Time Frame

Measured at baseline and 12 months

Title

Change in Aortic Pulse Wave Velocity

Time Frame

Measured at baseline,12 months

Secondary Outcome Measure Information:

Title

Change in Left Ventricular Mass Index

Time Frame

Measured at baseline and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 21 years Serum bicarbonate 22-25 mEq/L on 2 separate measurements (at least 1 day apart) CKD stage 3B or 4 at time of screening (eGFR 15-44 ml/min/1.73m2) Blood pressure <130/80 mm Hg prior to randomization BMI < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients). Able to provide consent Stable anti-hypertensive regimen for at least one month prior to randomization Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin). Exclusion Criteria: Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda) Uncontrolled hypertension Serum potassium < 3.3 or ≥ 5.5 mEq/L at screening New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months Factors judged to limit adherence to interventions Anticipated initiation of dialysis or kidney transplantation within 12 months Current participation in another research study Pregnancy or planning to become pregnant or currently breastfeeding Chronic use of supplemental oxygen Use of immunosuppression in past 3 months Metal implant or implanted electrical device (patient will be unable to get MRI)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessica Kendrick, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado Denver

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

At the conclusion of the study, data, which has been stripped of all personal identification information and coded with a number, will be made available to qualified individuals within the scientific community who apply for data use. The results and outcomes of this study will be made generally available by publication and journal articles submitted to PubMed Central in compliance with NIH access guidelines.

Learn more about this trial

Bicarbonate Administration in CKD

We'll reach out to this number within 24 hrs