The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) (BASE)
Chronic Kidney Disease
About this trial
This is an interventional other trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- 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)
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
- Blood pressure <160/100 mm Hg at screening (must be <150/100 mm Hg prior to randomization)
- Lean body weight 38.0-96.0 kg at the time of screening
- Age allowing legal consent without parental involvement (18-21 years, depending on individual state regulations)
- Able to provide consent
- Able to travel to study visits
- Able to read English
- In the opinion of the site investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations
- In the opinion of the site investigator, medically stable
Exclusion Criteria:
- 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
- On five or more antihypertensive and/or diuretic agents, regardless of the indication
- Serum potassium <3.3 or ≥5.5 mEq/L at screening (must be 3.5-5.5 mEq/L prior to randomization)
- Self-reported vegetarian
- 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
- Frequent urinary tract infections (≥2 in the past year)
- Presence of indwelling urinary catheter or urinary conduit (such as neobladder or urostomy)
- 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)
- Organ transplant recipients (excluding cornea)
- Active glomerular disease requiring or potentially requiring immunosuppressive treatment
- Chronic immunosuppressive therapy (for ≥3 months) for any indication. This does not include oral steroids <10 mg per day, inhaled steroids, or topical steroids
- Anticipated initiation of dialysis or kidney transplantation within 12 months as assessed by the site investigator
- Current participation in another interventional research study
- Malignancy requiring therapy within 2 years (basal or squamous cell skin carcinoma and localized prostate cancer are exempted)
- 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.
- Life expectancy <12 months as determined by the site investigator
- Institutionalized individuals, including prisoners and nursing home residents
- Plans to leave the immediate area within the next 12 months
- Routinely leaves town for multiple weeks each year such that protocol visits would be missed
- Chronic use of supplemental oxygen
- Use of both angiotensin-converting-enzyme inhibitor (ACEI) and Angiotensin II Receptor Blockers (ARBs)
Sites / Locations
- Denver Nephrology Research
- George Washington University
- Northwestern University
- Data Coordinating Center; Cleveland Clinic Foundation; Quantitative Health Sciences; 9500 Euclid Avenue
- Baylor/Scott & White
- University of Utah
- Utah VA
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Lower Dose Sodium Bicarbonate
Higher Dose Sodium Bicarbonate
Placebo
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.)
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.)
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.)