NCT05918029

Bone in CKD Alkali Response (BICARb Pilot Trial)

Bone in CKD Alkali Response Pilot Trial (BICARb)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 5 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Kidney Diseases
• Bone Loss

Interventions

Type	Name	Description
DRUG	Potassium Citrate Extended Release Oral Tablet	Oral potassium citrate extended-release tablet
OTHER	Placebo	Placebo capsule identical to active ingredient
DRUG	Potassium Citrate and Citric Acid Oral Solution	Oral potassium citrate and citric acid

Timeline

• Start date: 2024-08-15
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2023-06-26
• Last updated: 2024-10-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study