Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) (BASE)
Number of Subjects in Study Archive: 192
Study Design: Interventional
Conditions: Kidney Diseases
Duration: September 2015 – Present
# Recruitment Centers: 7
Treatment: Sodium bicarbonate
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL: https://clinicaltrials.gov/ct2/show/NCT02521181
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.
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.
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
- Patients must be 18 years or older with moderate to severe chronic kidney disease at the time of screening to participate in this study.
- 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.
This study is ongoing.