NCT05918029 Bone in CKD Alkali Response (BICARb Pilot Trial)
| NCT ID | NCT05918029 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Albert Einstein College of Medicine |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 103 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2026-08 |
Trial Parameters
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Brief 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.
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 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, the participant and/or parent/guardian capable of providing informed consent and assent (assessed by the provider) Inclusion Criteria (Adult Inclusion): * Adults ≥ 18 years old * Estimated eGFR \>30 and \<90 ml/min/1.73m2 by the new CKD-Epi without race * Pre-menopausal women of childbearing age must have had a menstrual period in the last month * Levels of PTH and alkaline phosphatase within 2x n
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