Bone in CKD Alkali Response (BICARb Pilot Trial)

Part of paid clinical trials in The Bronx, New York.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT05918029
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Bone Loss
  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
5 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Potassium Citrate Extended Release Oral Tablet — DRUG
    Oral potassium citrate extended-release tablet
  • Placebo — OTHER
    Placebo capsule identical to active ingredient
  • Potassium Citrate and Citric Acid Oral Solution — DRUG
    Oral potassium citrate and citric acid

Study Details

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.

Key Dates

Start date
Aug 15, 2024
Status verified
Oct 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
103 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Potassium Citrate
    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
  • Placebo Comparator: Placebo
    Placebo capsules identical to the active capsules.

Primary Outcome Measure

Change in Total volumetric bone mineral density (BMD) - Distal Radius [ Time Frame: Baseline to 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Albert Einstein College of MedicineThe BronxNew York10461
Jordan Nacimba
[email protected]
718-430-3301
Kimberly L Reidy, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Juhi Kumar, MD
Juhi Kumar, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Albert Einstein College of Medicine· The Bronx, NYUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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