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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, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Metabolic Acidosis Drug: Sodium bicarbonate Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bicarbonate Administration in CKD
Actual Study Start Date : January 15, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Drug: Placebo



Primary Outcome Measures :
  1. Change in Brachial Artery Flow Mediated Dilation [ Time Frame: Measured at baseline, 1, 6 and 12 months ]
  2. Change in Aortic Pulse Wave Velocity [ Time Frame: Measured at baseline, 6 and 12 months ]

Secondary Outcome Measures :
  1. Change in Left Ventricular Mass Index [ Time Frame: Measured at baseline and 12 months ]

Other Outcome Measures:
  1. Changes in Plasma Angiotensin II [ Time Frame: Measured at baseline, 1, 6 and 12 months ]
  2. Changes in Aldosterone [ Time Frame: Measured at baseline, 1, 6 and 12 months ]
  3. Changes in Endothelin-1 [ Time Frame: Measured at baseline, 1, 6 and 12 months ]
  4. Change in Serum T50 [ Time Frame: Measured at baseline, 1, 6 and 12 months ]


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915601


Contacts
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Contact: Jessica Kendrick, MD 303-602-5012 Jessica.Kendrick@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Jessica Kendrick, MD    303-602-5012    Jessica.Kendrick@ucdenver.edu   
Principal Investigator: Jessica Kendrick, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Jessica Kendrick, MD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02915601    
Other Study ID Numbers: 16-1572
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
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.
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acidosis
Urologic Diseases
Renal Insufficiency
Acid-Base Imbalance
Metabolic Diseases