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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02521181
Other study ID # DK099877-B
Secondary ID U01DK099877
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2015
Est. completion date June 2018

Study information

Verified date October 2020
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 194
Est. completion date June 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Drug:
Lower Dose Sodium Bicarbonate
Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)
Higher Dose Sodium Bicarbonate
Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)
Placebo
Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate

Locations

Country Name City State
United States Northwestern University Chicago Illinois
United States Data Coordinating Center; Cleveland Clinic Foundation; Quantitative Health Sciences; 9500 Euclid Avenue Cleveland Ohio
United States Denver Nephrology Research Denver Colorado
United States University of Utah Salt Lake City Utah
United States Utah VA Salt Lake City Utah
United States Baylor/Scott & White Temple Texas
United States George Washington University Washington District of Columbia

Sponsors (3)

Lead Sponsor Collaborator
Jennifer Gassman, PhD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants in Each Dose Arm Prescribed (i) Full Randomized Sodium Bicarbonate Dose at End of 28 Weeks & (ii) at Least 25% of Randomized Sodium Bicarbonate Dose at End of 28 Weeks as a Proportion of the Number Randomized to That Group 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. Baseline, 28 weeks
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