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.
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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

Kimberly Reidy, MD

718-655-1120

kreidy@montefiore.org

CONTACT