CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 194 enrolled
Drug / intervention
Lower Dose Sodium Bicarbonate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02521181
NCT02521181Phase 3Completed
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The BASE Study: Bicarbonate Administration to Stabilize eGFR

Jennifer Gassman, PhD·interventional·Posted Aug 13, 2015·Updated Oct 20, 2020

In Brief

A Phase 3 clinical trial evaluating Lower Dose Sodium Bicarbonate, Higher Dose Sodium Bicarbonate, and 1 other intervention for Chronic Kidney Disease. Completed, enrolled 194 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Cleveland Clinic

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 13, 2015
Enrollment StartOct 1, 2015
Primary CompletionJan 1, 2018
Study CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.9 years ago

Interventions

Lower Dose Sodium Bicarbonatedrug

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

Higher Dose Sodium Bicarbonatedrug

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

Placebodrug

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