Bone in CKD Alkali Response Pilot Trial (BICARb)
Albert Einstein College of Medicine
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.
Description
Chronic kidney disease is associated with bone loss and fractures in both children and adults, but bone protective therapies that are both proven and safe to use across the life-course in CKD are lacking. In this study, the investigators will conduct a pilot, double-blinded, randomized, placebo-controlled trial in 15 children and 88 adults evaluating the skeletal effects of potassium alkali therapy. These data will form the basis for a larger U01 proposal to determine the efficacy of potassium citrate on mitigating the effects of CKD on bone.
Eligibility
- Age range
- 5–100 years
- Sex
- All
- Healthy volunteers
- No
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 phosphorus within the normal range for age (per local laboratory reference assay) * 25-hydroxy Vitamin D ≥ 20 ng/mL * Females of child-bearing potential must be willing to use one form of effective contraception over the course of the study * Proficiency in English or Spanish * For participants \< 18 years,…
Interventions
- DrugPotassium Citrate Extended Release Oral Tablet
Oral potassium citrate extended-release tablet
- OtherPlacebo
Placebo capsule identical to active ingredient
- DrugPotassium Citrate and Citric Acid Oral Solution
Oral potassium citrate and citric acid
Locations (2)
- Albert Einstein College of MedicineThe Bronx, New York
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania