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

General Description

Sodium bicarbonate 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.

Objectives

To 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 in individuals with chronic kidney disease.

Outcome Measure

Primary Outcome Measures:

• Percentage of participants in each dose arm who are prescribed (i) full randomized sodium bicarbonate dose per protocol at end of 28 weeks and (ii) at least 25% of randomized sodium bicarbonate dose per protocol at end of 28 weeks.

Secondary Outcome Measures:

• Change in Urinary ammonium excretion from baseline to 28 weeks

Criteria

Inclusion Criteria:

• Patients must be 18 years or older with moderate to severe chronic kidney disease at the time of screening to participate in this study.

Exclusion Criteria:

• Patients less than 18 years or older and/or do not have severe chronic kidney disease at the time of screening may not participate in this study.

Outcome

This study is ongoing.