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Bicarbonate Administration in CKD

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ClinicalTrials.gov Identifier: NCT02915601
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE September 23, 2016
First Posted Date  ICMJE September 27, 2016
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE January 15, 2017
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
  • Change in Brachial Artery Flow Mediated Dilation [ Time Frame: Measured at baseline, 1, 6 and 12 months ]
  • Change in Aortic Pulse Wave Velocity [ Time Frame: Measured at baseline, 6 and 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
Change in Left Ventricular Mass Index [ Time Frame: Measured at baseline and 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 23, 2016)
  • Changes in Plasma Angiotensin II [ Time Frame: Measured at baseline, 1, 6 and 12 months ]
  • Changes in Aldosterone [ Time Frame: Measured at baseline, 1, 6 and 12 months ]
  • Changes in Endothelin-1 [ Time Frame: Measured at baseline, 1, 6 and 12 months ]
  • Change in Serum T50 [ Time Frame: Measured at baseline, 1, 6 and 12 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bicarbonate Administration in CKD
Official Title  ICMJE Bicarbonate Administration in CKD
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • Metabolic Acidosis
Intervention  ICMJE
  • Drug: Sodium bicarbonate
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Sodium Bicarbonate
    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.
    Intervention: Drug: Sodium bicarbonate
  • Placebo Comparator: Placebo
    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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2016)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jessica Kendrick, MD 303-602-5012 Jessica.Kendrick@ucdenver.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02915601
Other Study ID Numbers  ICMJE 16-1572
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jessica Kendrick, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP