NCT05918029 · Albert Einstein College of Medicine
Bone in CKD Alkali Response (BICARb Pilot Trial)
(BICARb)
What this study is about
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.
View original scientific 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.
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
Primary outcome measures
Change in Total volumetric bone mineral density (BMD) - Distal Radius
Time frame: Baseline to 6 months
Change in total volumetric BMD will be analyzed by high resolution peripheral quantitative computed tomography (HR-pQCT). The 6-month absolute and relative (percent) changes in Z-score in distal radius total volumetric BMD will summarized by study arm and analyzed for between group treatment changes.
Change in Total volumetric bone mineral density (BMD) - Tibia
Time frame: Baseline to 6 months
Change in total volumetric BMD will be analyzed by high resolution peripheral quantitative computed tomography (HR-pQCT). The 6-month absolute and relative (percent) changes in Z-score in tibia total volumetric BMD will summarized by study arm and analyzed for between group treatment changes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (Pediatric Inclusion):
- 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)
- 25-hydroxy Vitamin D ≥ 20 ng/mL
- Females of child-bearing potential must be willing to use one form of effective contraception over the course of the study
- Proficiency in English or Spanish
- For participants \< 18 years, the participant and/or parent/guardian capable of providing informed consent and assent (assessed by the provider) Inclusion Criteria (Adult Inclusion):
- Adults ≥ 18 years old
- Estimated eGFR \>30 and \<90 ml/min/1.73m2 by the new CKD-Epi without race
- Pre-menopausal women of childbearing age must have had a menstrual period in the last month
- Levels of PTH and alkaline phosphatase within 2
Where
- The Bronx, New York
- Pittsburgh, Pennsylvania
Collaborators
Columbia University, University of Pittsburgh Medical Center, University of Utah, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2024 · Source of record for eligibility and locations