Bone in CKD Alkali Response (BICARb Pilot Trial)
Recruiting
Phase 2
Phase 3
Interventional Study
Chronic Kidney Diseases
Bone Loss
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 5 – 100
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 103 (estimated)
- Sponsor
- Albert Einstein College of Medicine · Other
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About This 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) underlying the effects of potassium citrate on skeletal health.
Participants will be asked to:
* pr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria (Pediatric Inclusion):
* Children 5-17 years old
* Estimated eGFR \>30 and \<90 ml/min/1.73m2 by CKiD U25 equations
* Females of child-bearing potential must have had a menstrual period in the last month
* Levels of PTH and alkaline phosphatase within 2x normal range and phosphor…
Contacts