NCT02521181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2015

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

April 27, 2015

Results QC Date

August 14, 2020

Last Update Submit

October 19, 2020

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Lower Dose Sodium Bicarbonate

EXPERIMENTAL

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

Higher Dose Sodium Bicarbonate

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Lower Dose Sodium BicarbonateDRUG

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

Lower Dose Sodium Bicarbonate
Higher Dose Sodium BicarbonateDRUG

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

Higher Dose Sodium Bicarbonate
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Denver Nephrology Research

Denver, Colorado, 80230, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

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

Cleveland, Ohio, 44195-5196, United States

Location

Baylor/Scott & White

Temple, Texas, 76502, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Utah VA

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • 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.

    PMID: 38170601DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Jennifer J. Gassman, PhD
Organization
Cleveland Clinic Foundation
gassmaj@ccf.org
(216) 444-9938

Study Officials

  • Michael F. Flessner, MD, PhD

    DKUHD, NIDDK, NIH

    STUDY DIRECTOR

  • John W. Kusek, PhD

    DKUHD, NIDDK, NIH

    STUDY DIRECTOR

  • Linda Fried, MD, MPH

    VA Pittsburgh Healthcare System

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator-Data Coordinating Center

Study Record Dates

First Submitted

April 27, 2015

First Posted

August 13, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

October 20, 2020

Results First Posted

October 20, 2020

Record last verified: 2020-10

Locations

US(7)