Clinical Trial Details
| Trial ID: | L0342 |
| Source ID: | NCT02521181 |
| Associated Drug: | Lower Dose Sodium Bicarbonate |
| Title: | The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) |
| Acronym: | BASE |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02521181/results |
| Conditions: | Chronic Kidney Disease |
| Interventions: | DRUG: Lower Dose Sodium Bicarbonate|DRUG: Higher Dose Sodium Bicarbonate|DRUG: Placebo |
| Outcome Measures: | Primary: Number of Participants in Each Dose Arm Prescribed (i) Full Randomized Sodium Bicarbonate Dose at End of 28 Weeks & (ii) at Least 25% of Randomized Sodium Bicarbonate Dose at End of 28 Weeks as a Proportion of the Number Randomized to That Group, The prescribed dose for each participant at the end of 28 weeks will be determined by the safety and tolerability of each dose during the intervention period. The primary assessments will examine the percentage of participants in each dose arm who are prescribed (i) the full randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks and (ii) at least 25% of the randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks. The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight per day., Baseline, 28 weeks | |
| Sponsor/Collaborators: | Sponsor: Jennifer Gassman, PhD | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|The Cleveland Clinic |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 194 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER |
| Start Date: | 2015-10 |
| Completion Date: | 2018-06 |
| Results First Posted: | 2020-10-20 |
| Last Update Posted: | 2020-10-20 |
| Locations: | Denver Nephrology Research, Denver, Colorado, 80230, United States|George Washington University, Washington, District of Columbia, 20037, United States|Northwestern University, Chicago, Illinois, 60611, United States|Data Coordinating Center; Cleveland Clinic Foundation; Quantitative Health Sciences; 9500 Euclid Avenue, Cleveland, Ohio, 44195-5196, United States|Baylor/Scott & White, Temple, Texas, 76502, United States|University of Utah, Salt Lake City, Utah, 84112, United States|Utah VA, Salt Lake City, Utah, 84112, United States |
| URL: | https://clinicaltrials.gov/show/NCT02521181 |
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