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RECRUITING
NCT05918029
PHASE2/PHASE3

Bone in CKD Alkali Response (BICARb Pilot Trial)

Sponsor: Albert Einstein College of Medicine

View on ClinicalTrials.gov

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.

Official title: Bone in CKD Alkali Response Pilot Trial (BICARb)

Key Details

Gender

All

Age Range

5 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

103

Start Date

2024-08-15

Completion Date

2026-08

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

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

Locations (2)

Albert Einstein College of Medicine

The Bronx, New York, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States