RecruitingPhase 2/3

Bone in CKD Alkali Response (BICARb Pilot Trial)

United States103 participantsStarted 2024-08-15

Plain-language 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.

Who can participate

Age range

5 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 normal range and phosphorus up to 5.0 mg/dL (per local laboratory reference assay) * Levels of 25-hydroxy Vitamin D ≥ 20 ng/mL * Women of childbearing potential must be willing to use one form of effective contraception over the course of the study * Proficiency in English or Spanish Exclusion Criteria (Pediatric and Adult): * Baseline potassium ≥ 5.5 mEq/L or prior history of hyperkalemia in the last 6 months (potassium \> 5.5 mEq/L) or currently taking a potassium lowering agent * Alkali t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Total volumetric bone mineral density (BMD) - Distal Radius

Timeframe: Baseline to 6 months

Change in Total volumetric bone mineral density (BMD) - Tibia

Timeframe: Baseline to 6 months

Trial details

NCT IDNCT05918029

SponsorAlbert Einstein College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Kimberly Reidy, MD

718-655-1120 kreidy@montefiore.org

View on ClinicalTrials.gov More Chronic Kidney Diseases trials