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

NCT02521181 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2020-10-20

Study results available
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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

Interventions

DRUG

Lower Dose Sodium Bicarbonate

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

DRUG

Higher Dose Sodium Bicarbonate

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

DRUG

Placebo

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

Sponsors & Collaborators

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

    collaborator NIH

  • The Cleveland Clinic

    collaborator OTHER

  • Jennifer Gassman, PhD

    lead OTHER

Principal Investigators

  • Michael F. Flessner, MD, PhD · DKUHD, NIDDK, NIH

  • John W. Kusek, PhD · DKUHD, NIDDK, NIH

  • Linda Fried, MD, MPH · VA Pittsburgh Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-01-31
Completion
2018-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02521181 on ClinicalTrials.gov