Bone in CKD Alkali Response (BICARb Pilot Trial)

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age5-100
SponsorAlbert Einstein College of Medicine

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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 therapy within the prior 12 months

Baseline ECG with abnormalities associated with increased risk of arrythmia, excluding left ventricular hypertrophy

Baseline serum bicarbonate levels < 17 or ≥ 30 mEq/L

Trial design

Treatments tested in this trial

  • Potassium Citrate Extended Release Oral Tablet
  • Placebo
  • Potassium Citrate and Citric Acid Oral Solution

Treatment groups

103 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Albert Einstein College of Medicine

Lead sponsor

Columbia University

Collaborator

University of Pittsburgh Medical Center

Collaborator

University of Utah

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator