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
Access to samples for Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) (BASE) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL:
https://clinicaltrials.gov/ct2/show/NCT02521181
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.