Kidney disease

Bone in CKD Alkali Response (BICARb Pilot Trial)

Recruiting · 2 sites across 2 states

✓ Study treatment at no cost✓ PHASE2, PHASE3

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

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 this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

•Children age 5–17 or adults age 18 or older with chronic kidney disease (CKD).
•Kidney function must be estimated between >30 and <90 ml/min/1.73m2 using specified kidney equations (CKiD U25 for children; CKD-Epi without race for adults).
•People who can become pregnant must have had a menstrual period in the last month and be willing to use effective contraception during the study.
•Vitamin D level (25-hydroxy Vitamin D) must be at least 20 ng/mL.
•Able to do study steps and (for those under 18) the participant and/or parent/guardian can provide informed consent and assent (as assessed by the provider).

🚫 You may not be able to join if…

•Potassium is too high at the start (baseline potassium ≥ 5.5 mEq/L) or there was hyperkalemia in the last 6 months, or they are currently taking a potassium-lowering agent.
•They took alkali therapy in the prior 12 months.
•ECG heart tracing has certain abnormalities that raise the risk of abnormal heart rhythm (arrhythmia), other than left ventricular hypertrophy.
•Bicarbonate level is too low or too high (less than 17 or at least 30 mEq/L).
•They are pregnant or breastfeeding (also not allowed: prisoners/institutionalized people, or unwilling to provide informed consent).

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults roughly 5–100
✓Have Kidney disease

!Some conditions may not be a fit: Heart / cardiovascular disease, COPD (chronic lung disease)
!Not for people who are pregnant or breastfeeding

What to expect, step by step

1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

Yes. This treatment has already been through earlier human studies for safety before reaching this stage.

What you need to know before you apply

What is this study testing?+

Is it safe? Who makes sure of that?+

This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT05918029 · Locations: New York · Pennsylvania