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Placebo

Potassium Citrate for Kidney Disease (BICARb Trial)

Phase 2 & 3

Recruiting

Led By Michal Melamed, MD

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For children: Estimated eGFR >30 and <90 ml/min/1.73m2 by CKiD U25 (For Pediatric participants) equations

Females of child-bearing potential must have had a menstrual period in the last month

Must not have

Solid or liquid organ transplant

Previous bilateral wrist and tibia fractures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial tests if potassium citrate can improve bone health in adults & kids with kidney disease. Participants will provide blood & urine samples, answer health/diet questions & take either potassium citrate or placebo for 6 months. Results from bone imaging will be compared.

Who is the study for?

This trial is for adults and children over 5 with chronic kidney disease who have normal PTH, phosphorus, and vitamin D levels. Women must use contraception and not be pregnant or breastfeeding. Participants can't join if they have certain metabolic bone diseases, high potassium levels, heart risks on ECG, severe other illnesses affecting acid-base balance, a history of kidney stones or limb amputations.

What is being tested?

The study tests if potassium citrate improves bone health in those with chronic kidney disease by comparing it to a placebo. Over 8 months, participants will take pills for safety checks then either the treatment or placebo for 6 months while undergoing blood tests, diet surveys, and advanced bone scans.

What are the potential side effects?

While the description doesn't list specific side effects of potassium citrate in this context directly; generally it may cause digestive discomfort like nausea or diarrhea and increase the risk of developing high blood potassium levels which could affect heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child's kidney function is moderately reduced but not severely.

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I have had a menstrual period in the last month.

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I am 5 years old or older.

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My kidney function is moderately reduced but not severely.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a solid or liquid organ transplant.

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I have had fractures in both my wrists and shins.

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I do not have a bone disease unrelated to kidney issues.

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I have untreated thyroid issues or Cushing's syndrome.

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My urine is very alkaline or I have had kidney stones.

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I have had a lower limb amputated or I cannot walk.

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I haven't used specific bone or hormone treatments in the last year.

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I have a serious health condition that affects my body's acid-base balance.

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My kidney function is rapidly declining, or I am on dialysis or expect to start dialysis or have a transplant soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Change in 24-hour Urine Net Acid Excretion (NAE)

Change in Parathyroid Hormone (PTH) levels

Change in circulating biomarkers of bone formation

+1 more

Other study objectives

Changes in TRAP5b

Changes in bone alkaline phosphatase

Changes in bone quality

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Potassium CitrateExperimental Treatment2 Interventions

Potassium Citrate extended-release tablets 30 mEq twice daily. 1 mEq/kg/day divided into two doses for children to a maximum dose of 30 mEq twice daily. OR (for children who cannot take pills): Potassium citrate and citric acid for oral solution 1 mEq/kg/day divided into two doses to a maximum dose of 30 mEq twice daily

Group II: PlaceboPlacebo Group1 Intervention

Placebo capsules identical to the active capsules.

0 / 13Eligibility criteria met