The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR)

NCT ID: NCT02521181

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-06-30

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.)

Group Type: EXPERIMENTAL

Lower Dose Sodium Bicarbonate

Intervention Type: DRUG

Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)

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.)

Group Type: EXPERIMENTAL

Higher Dose Sodium Bicarbonate

Intervention Type: DRUG

Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)

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.)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate

Interventions

Lower Dose Sodium Bicarbonate

Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)

Intervention Type: DRUG

Higher Dose Sodium Bicarbonate

Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)

Intervention Type: DRUG

Placebo

Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Jennifer Gassman, PhD

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Gassman, PhD

Principal Investigator-Data Coordinating Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael F. Flessner, MD, PhD

Role: STUDY_DIRECTOR

DKUHD, NIDDK, NIH

John W. Kusek, PhD

Role: STUDY_DIRECTOR

DKUHD, NIDDK, NIH

Linda Fried, MD, MPH

Role: STUDY_CHAIR

VA Pittsburgh Healthcare System

Locations

Denver Nephrology Research

Denver, Colorado, United States

George Washington University

Washington D.C., District of Columbia, United States

Northwestern University

Chicago, Illinois, United States

Data Coordinating Center; Cleveland Clinic Foundation; Quantitative Health Sciences; 9500 Euclid Avenue

Cleveland, Ohio, United States

Baylor/Scott & White

Temple, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Utah VA

Salt Lake City, Utah, United States

Countries

United States

References

Raphael KL, Katz R, Larive B, Kendrick C, Isakova T, Sprague S, Wolf M, Raj DS, Fried LF, Gassman J, Hoofnagle A, Cheung AK, Ix JH. Oral Sodium Bicarbonate and Bone Turnover in CKD: A Secondary Analysis of the BASE Pilot Trial. J Am Soc Nephrol. 2024 Jan 1;35(1):57-65. doi: 10.1681/ASN.0000000000000264. Epub 2023 Dec 4.

Reference Type: DERIVED

PMID: 38170601 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U01DK099877

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK099877-B

Identifier Type: -

Identifier Source: org_study_id