Chronic Kidney DiseaseNCT02915601
Bicarbonate Administration in CKD
A study testing Sodium bicarbonate in people with Chronic Kidney Disease and Metabolic Acidosis, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Metabolic Acidosis
- What is being tested?
- Sodium bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2017to 19 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
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
- Being tested
- Sodium bicarbonate, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brachial Artery Flow Mediated Dilation
Measured: Measured at baseline and 12 months
Change in Aortic Pulse Wave Velocity
Measured: Measured at baseline,12 months
Secondary outcomes (1)
Change in Left Ventricular Mass Index
Measured: Measured at baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start15 Jan 2017
- Primary completion19 May 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Kendrick, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915601
- Sponsor's protocol ID
- 16-1572
- Status last verified
- Jun 2023
- First submitted
- 23 Sep 2016
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38568010Perez 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.
PubMed 37889573Kendrick 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.
PubMed 37228030
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bicarbonate Administration in CKD
- ClinicalTrials.gov ID
- NCT02915601
- Acronym / sponsor ID
- 16-1572
- Conditions
- Chronic Kidney Disease, Metabolic Acidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Posted 25 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Bicarbonate | Experimental | Drug: Sodium bicarbonateParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonate | Drug | Sodium Bicarbonate |
| Placebo | Drug | Placebo |
Primary outcome
Change in Brachial Artery Flow Mediated Dilation
Time frame: Measured at baseline and 12 months
Change in Aortic Pulse Wave Velocity
Time frame: Measured at baseline,12 months
1 secondary outcome
Change in Left Ventricular Mass Index
Time frame: Measured at baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38568010Zhang 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.
- Derived from this study: PubMed 37889573Perez 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.
- Derived from this study: PubMed 37228030Kendrick 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Kendrick, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium bicarbonate in people with Chronic Kidney Disease and Metabolic Acidosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brachial Artery Flow Mediated Dilation (time frame: Measured at baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02915601, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.