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Bone in CKD Alkali Response (BICARb Pilot Trial)

NCT05918029 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Diseases
  • Bone Loss

Interventions

DRUG

Potassium Citrate Extended Release Oral Tablet

Oral potassium citrate extended-release tablet

OTHER

Placebo

Placebo capsule identical to active ingredient

DRUG

Potassium Citrate and Citric Acid Oral Solution

Oral potassium citrate and citric acid

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • University of Utah

    collaborator OTHER

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

    collaborator NIH

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Kimberly Reidy, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918029 on ClinicalTrials.gov