Bicarbonate Administration in CKD

NCT02915601 | Completed Results DMC

• 1 other identifier: 16-1572
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Metabolic Acidosis

Outcome Measures

Primary Outcomes (2)

• Change in Brachial Artery Flow Mediated Dilation

  Measured at baseline and 12 months

• Change in Aortic Pulse Wave Velocity

  Measured at baseline,12 months

Secondary Outcomes (1)

• Change in Left Ventricular Mass Index

  Measured at baseline and 12 months

Study Arms (2)

Sodium Bicarbonate

EXPERIMENTAL

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.

Drug: Sodium bicarbonate

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Sodium bicarbonate DRUG

Sodium Bicarbonate

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

• Zhang A, Furgeson S, Shapiro A, Bjornstad P, You Z, Tommerdahl KL, Dixon A, Stenson E, Oh E, Kendrick J. Assessing Cognition in CKD Using the National Institutes of Health Toolbox. Kidney360. 2024 Jun 1;5(6):834-840. doi: 10.34067/KID.0000000000000440. Epub 2024 Apr 3.

  PMID: 38568010 DERIVED

• Perez L, You Z, Kendrick J. Association of Plant-Based Protein Intake with Cognitive Function in Adults with CKD. Kidney360. 2023 Nov 1;4(11):1554-1561. doi: 10.34067/KID.0000000000000278. Epub 2023 Oct 27.

  PMID: 37889573 DERIVED

• Kendrick J, You Z, Andrews E, Farmer-Bailey H, Moreau K, Chonchol M, Steele C, Wang W, Nowak KL, Patel N. Sodium Bicarbonate Treatment and Vascular Function in CKD: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2023 Aug 1;34(8):1433-1444. doi: 10.1681/ASN.0000000000000161. Epub 2023 May 25.

  PMID: 37228030 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acidosis

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Jessica Kendrick
• Organization: University of Colorado Anschutz Medical Campus

Jessica.Kendrick@cuanschutz.edu

3037244837

Study Officials

• Jessica Kendrick, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 27, 2016
• Study Start: January 15, 2017
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: July 25, 2023
• Results First Posted: July 25, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)