RecruitingPhase 2Phase 3NCT05918029

Bone in CKD Alkali Response (BICARb Pilot Trial)

Bone in CKD Alkali Response Pilot Trial (BICARb)


Sponsor

Albert Einstein College of Medicine

Enrollment

103 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing whether bicarbonate (a type of alkali/base supplement, like baking soda in a medical form) can improve bone health in children and adults with chronic kidney disease (CKD) who have mild metabolic acidosis (too much acid in the blood). **You may be eligible if...** - Children: ages 5–17 with an estimated GFR of 30–90 ml/min/1.73m2 (moderate kidney disease) - Adults: ages 18–70 with similar kidney function range - Your PTH, alkaline phosphatase, phosphorus, and vitamin D levels are within acceptable ranges - You have mild to moderate metabolic acidosis (low bicarbonate level in blood) **You may NOT be eligible if...** - You are already on dialysis - You are currently taking bicarbonate supplements or alkali therapy - You have very high or very low blood potassium or calcium - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 Medicine

The Bronx, New York, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05918029


Related Trials