Bone in CKD Alkali Response (BICARb Pilot Trial)
| Condition | Chronic Kidney Diseases, Bone Loss |
|---|---|
| Phase | Phase 2/3 |
| Sponsor | Albert Einstein College of Medicine |
| Status | Terminated |
| Enrollment | 6 participants |
| Interventions | Potassium Citrate Extended Release Oral Tablet, Potassium Citrate and Citric Acid Oral Solution |
| Start date | Aug 15, 2024 |
| Completion date | May 16, 2025 |
| Results posted | Jul 28, 2026 |
Summary
The goal of this clinical trial is to test whether potassium citrate improves skeletal health in adults and children with chronic kidney disease. The main questions it aims to answer are: * To evaluate effects of potassium citrate treatment on bone quality and strength. * To evaluate mechanism(s) underlying the effects of potassium citrate on skeletal health. Participants will be asked to: * provide blood, urine and answer questions about health and diet three times during an 8 months period * undergo advanced bone imaging with high resolution-peripheral quantitative CT scan twice during 8 months * take study pills for 4-6 weeks at the beginning of the study to ensure safety * take either potassium citrate or placebo for 6 months during the blinded portion of the study As part of the study, there will be a run-in period followed by the placebo-controlled randomized clinical trial. Researchers will compare the bone imaging between the potassium citrate and the placebo groups at the end of the study.
Change in Total Volumetric Bone Mineral Density (BMD) - Distal Radius
Change in Total Volumetric Bone Mineral Density (BMD) - Tibia
Open in BENITIONS View on ClinicalTrials.gov
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