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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: Recruiting Phase 2 study of Chronic Kidney Diseases and Bone Loss, sponsored by Albert Einstein College of Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in total volumetric BMD will be analyzed by high resolution peripheral quantitative computed tomography (HR-pQCT). The 6-month absolute and relative (percent) changes in Z-score in distal radius total volumetric BMD will summarized by study arm and analyzed for between group treatment changes.
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 |
What NCT05918029 shows while recruiting
NCT05918029 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 443-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05918029's enrollment target sits among peer trials
103 38th of 73 higher than 36 of 73 other Chronic Kidney Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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