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Terminated NCT05918029

Bone in CKD Alkali Response (BICARb Pilot Trial)

Conditions: Chronic Kidney Diseases, Bone Loss

Sex: All
Ages: 5 Years – 100 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 6
Sponsor: Albert Einstein College of Medicine

Location: Albert Einstein College of Medicine The Bronx New York

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 glomerular filtration rate (eGFR) ≥ 30 and \ 8 or history of nephrolithiasis * Lower extremity amputations or non-ambulatory * Metabolic bone disease not related to CKD (e.g., Paget's disease, primary hyperparathyroidism) * Endocrinopathy: untreated hyper or hypothyroidism, Cushing's syndrome * Medical diseases that can affect therapy (severe myocardial damage, acute dehydration, delayed gastric emptying, esophageal compression, or intestinal obstruction or stricture) * Use of bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, raloxifene, estrogen or testosterone replacement therapy, or an unstable dose of glucocorticoids within the 12-months prior to enrollment * Previous bilateral wrist and tibia fractures * Solid or liquid organ transplant * On dialysis or with rapidly deteriorating kidney function or expectation for transplantation or initiation of dialysis in less than 3 months * Pregnancy or breastfeeding * Prisoners or institutionalized individuals * Unwillingness to provide informed consent

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05918029). StuddyBuddy aggregates publicly available trial information.