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NCT05918029 · ClinicalTrials.gov registry record · Phase 2
Bone in CKD Alkali Response (BICARb Pilot Trial)
A Phase 2 study of Chronic Kidney Diseases and Bone Loss, sponsored by Albert Einstein College of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
- 2
- Study locations
NCT05918029 is a Phase 2 study of Chronic Kidney Diseases and Bone Loss that is actively recruiting participants, run by Albert Einstein College of Medicine. The registered enrollment target is 103 participants, below the 443-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05918029, a Phase 2 study of Chronic Kidney Diseases and Bone Loss, is actively recruiting participants, sponsored by Albert Einstein College of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Potassium Citrate Extended Release Oral Tablet
- DRUG Potassium Citrate and Citric Acid Oral Solution
Study Locations (2)
New York
- Albert Einstein College of Medicine - The Bronx
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2024-08-15 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05918029
The ClinicalTrials.gov registry entry for NCT05918029 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 443-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (77% lower). The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Kidney Diseases appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05918029 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05918029 about?
NCT05918029 is a clinical study titled "Bone in CKD Alkali Response (BICARb Pilot Trial)". 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) u...
What is the current status of trial NCT05918029?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2024-08-15. Estimated completion is 2026-08.
What conditions does trial NCT05918029 study?
This clinical trial studies the following conditions: Chronic Kidney Diseases, Bone Loss.
What interventions are being tested in trial NCT05918029?
The interventions under investigation include: Placebo (OTHER), Potassium Citrate Extended Release Oral Tablet (DRUG), Potassium Citrate and Citric Acid Oral Solution (DRUG).
Who is sponsoring clinical trial NCT05918029?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05918029 being conducted?
This trial has 2 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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