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Trial record 1 of 1 for:    NCT02521181
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The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) (BASE)

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ClinicalTrials.gov Identifier: NCT02521181
Recruitment Status : Active, not recruiting
First Posted : August 13, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Jennifer Gassman, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight (LBW) per day. Sodium bicarbonate, also known as baking soda, may help prevent kidney failure in people with chronic kidney disease. However, the dose to prescribe in order to test this possibility in a clinical trial is uncertain. The BASE pilot clinical trial will help determine the best dose of sodium bicarbonate to prescribe in a future study that will test the long-term safety and efficacy of sodium bicarbonate as a treatment to preserve kidney function in individuals with chronic kidney disease.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Lower Dose Sodium Bicarbonate Drug: Higher Dose Sodium Bicarbonate Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: The BASE Study: Bicarbonate Administration to Stabilize eGFR
Actual Study Start Date : October 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Lower Dose Sodium Bicarbonate
Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Drug: Lower Dose Sodium Bicarbonate
Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)

Experimental: Higher Dose Sodium Bicarbonate
Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Drug: Higher Dose Sodium Bicarbonate
Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)

Placebo Comparator: Placebo
Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Drug: Placebo
Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate




Primary Outcome Measures :
  1. Percentage of participants in each dose arm who are prescribed (i) full randomized sodium bicarbonate dose per protocol at end of 28 weeks and (ii) at least 25% of randomized sodium bicarbonate dose per protocol at end of 28 weeks. [ Time Frame: Baseline, 28 weeks ]
    The prescribed dose for each participant at the end of 28 weeks will be determined by the safety and tolerability of each dose during the intervention period. The primary assessments will examine the percentage of participants in each dose arm who are prescribed (i) the full randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks and (ii) at least 25% of the randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks. The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight per day.


Secondary Outcome Measures :
  1. Change in Urinary ammonium excretion in mEq/L from baseline to 28 weeks. [ Time Frame: Baseline, 28 weeks ]
    Sodium bicarbonate reduces urinary ammonium excretion (mEq/L). This outcome will determine if the 0.8 mEq/kg-lean body weight per day dose lowers urinary ammonium excretion more than the 0.5 mEq/kg-lean body weight per day dose.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Serum bicarbonate 20-28 mEq/L at screening (the average of the two most recent values in Baseline must be 20-28 mEq/L prior to randomization)
  2. Moderate to severe chronic kidney disease (CKD) at the time of screening, defined as one of the following:

    • eGFR 20-44 ml/min/1.73m2 or
    • eGFR 45-59 ml/min/1.73m2 plus random urinary albumin:creatinine (ACR) ≥100 mg/gm
  3. Blood pressure <160/100 mm Hg at screening (must be <150/100 mm Hg prior to randomization)
  4. Lean body weight 38.0-96.0 kg at the time of screening
  5. Age allowing legal consent without parental involvement (18-21 years, depending on individual state regulations)
  6. Able to provide consent
  7. Able to travel to study visits
  8. Able to read English
  9. In the opinion of the site investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations
  10. In the opinion of the site investigator, medically stable

Exclusion Criteria:

  1. Use of chronic daily oral alkali (such as sodium bicarbonate, sodium citrate, potassium citrate, etc) with one exception: calcium carbonate ≤1500 mg/day is allowed, as some will take this for the indication of bone health
  2. On five or more antihypertensive and/or diuretic agents, regardless of the indication
  3. Serum potassium <3.3 or ≥5.5 mEq/L at screening (must be 3.5-5.5 mEq/L prior to randomization)
  4. Self-reported vegetarian
  5. New York Heart Association Class 3 or 4 heart failure symptoms, known left ventricular ejection fraction ≤30%, or hospital admission for heart failure within the past 3 months
  6. Frequent urinary tract infections (≥2 in the past year)
  7. Presence of indwelling urinary catheter or urinary conduit (such as neobladder or urostomy)
  8. Factors judged to limit adherence to interventions (e.g., alcoholism, history of missing clinic visits, chronic gastrointestinal disorder that makes compliance with the intervention unreliable)
  9. Organ transplant recipients (excluding cornea)
  10. Active glomerular disease requiring or potentially requiring immunosuppressive treatment
  11. Chronic immunosuppressive therapy (for ≥3 months) for any indication. This does not include oral steroids <10 mg per day, inhaled steroids, or topical steroids
  12. Anticipated initiation of dialysis or kidney transplantation within 12 months as assessed by the site investigator
  13. Current participation in another interventional research study
  14. Malignancy requiring therapy within 2 years (basal or squamous cell skin carcinoma and localized prostate cancer are exempted)
  15. Pregnancy or planning to become pregnant or currently breast-feeding. Women of childbearing potential (pre-menopausal and not surgically sterilized) will have urine pregnancy test before enrollment.
  16. Life expectancy <12 months as determined by the site investigator
  17. Institutionalized individuals, including prisoners and nursing home residents
  18. Plans to leave the immediate area within the next 12 months
  19. Routinely leaves town for multiple weeks each year such that protocol visits would be missed
  20. Chronic use of supplemental oxygen
  21. Use of both angiotensin-converting-enzyme inhibitor (ACEI) and Angiotensin II Receptor Blockers (ARBs)

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): NCT02521181


Locations
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United States, Colorado
Denver Nephrology Research
Denver, Colorado, United States, 80230
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Ohio
Data Coordinating Center; Cleveland Clinic Foundation; Quantitative Health Sciences; 9500 Euclid Avenue
Cleveland, Ohio, United States, 44195-5196
United States, Texas
Baylor/Scott & White
Temple, Texas, United States, 76502
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Utah VA
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Jennifer Gassman
Investigators
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Study Director: Michael F. Flessner, MD, PhD DKUHD, NIDDK, NIH
Study Director: John W. Kusek, PhD DKUHD, NIDDK, NIH
Study Chair: Linda Fried, MD, MPH VA Pittsburgh Healthcare System

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Responsible Party: Jennifer Gassman, Principal Investigator-Data Coordinating Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT02521181     History of Changes
Other Study ID Numbers: DK099877-B
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency