| Trial ID: | L0266 |
| Source ID: | NCT05918029
|
| Associated Drug: |
Potassium Citrate Extended Release Oral Tablet
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| Title: |
Bone in CKD Alkali Response (BICARb Pilot Trial)
|
| Acronym: |
BICARb
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| Status: |
RECRUITING
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Chronic Kidney Diseases|Bone Loss
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| Interventions: |
DRUG: Potassium Citrate Extended Release Oral Tablet|OTHER: Placebo|DRUG: Potassium Citrate and Citric Acid Oral Solution
|
| Outcome Measures: |
Primary: Change in Total volumetric bone mineral density (BMD) - Distal Radius, 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., Baseline to 6 months|Change in Total volumetric bone mineral density (BMD) - Tibia, 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., Baseline to 6 months | Secondary: Change in 24-hour Urine Net Acid Excretion (NAE), Change in 24-hour urinary NAE from baseline will be assessed by analyzing samples obtained from 24-hour timed urine collections using laboratory titration methods. Results will be quantified and summarized by study arm using basic descriptive statistics and subsequently analyzed for between group treatment changes. Standard urinary NAE values vary but can range from 250-750 mg/24 hours (1.48 to 4.43 mmol/24 hours)., Baseline to 6 months|Change in Parathyroid Hormone (PTH) levels, Change in circulating PTH concentration from baseline will be assessed by the collection of blood samples via venipuncture and analysis for circulating PTH by an immunoassay. Results will be summarized by study arm using basic descriptive statistics and subsequently statistically analyzed for between group changes. Standard PTH reference ranges can vary but are generally between 10-65 pg/mL in plasma., Baseline to 6 months|Change in circulating biomarkers of bone resorption, Change in circulating biomarkers of bone resorption from baseline will be assessed following the collection of blood samples via venipuncture and subsequent analysis for circulating C-terminal telopeptides of type I collagen using a cross-linking telopeptide of type I collagen (CTX blood test) assay. C-terminal telopeptides can be used as a biomarker to measure bone resorption and turnover. Elevated levels of C-terminal telopeptide can be indicative of increased bone resorption. While standard reference ranges for C-terminal telopeptide can vary, for premenopausal women ranges are typically 40-465 pg/mL in serum and 19-83 ug/L in plasma., Baseline to 6 months|Change in circulating biomarkers of bone formation, Change in circulating biomarker of bone formation from baseline will be assessed following the collection of blood samples via venipuncture and subsequent analysis for procollagen type-1 N-terminal propeptide (P1NP). A P1NP assay measures the amount of amino-terminal propeptide of type I procollagen in the serum and can be used as biomarker to measure the rate of bone formation. While reference ranges can vary by age, standard reference ranges in adult premenopausal women are 19-83 ug/L., Baseline to 6 months | Other: Correlation of serum bicarbonate and urine NAE, Correlation coefficient will be determined between serum bicarbonate and urine net acid excretion. The correlation coefficient is a number between 0 and 1, with 0 being no correlation and 1 being perfect correlation., 6 months|Correlation of serum bicarbonate and bone quality, Correlation coefficient will be determined between serum bicarbonate and bone quality. The correlation coefficient is a number between 0 and 1, with 0 being no correlation and 1 being perfect correlation., 6 months|Correlation between urine net acid excretion and bone quality, Correlation coefficient will be determined between urine net acid excretion and bone quality. The correlation coefficient is a number between 0 and 1, with 0 being no correlation and 1 being perfect correlation., 6 months|Changes in bone alkaline phosphatase, Changes in bone alkaline phosphatase will be compared between the groups. Bone alkaline phosphatase is measured in IU/L. Higher values are indicative of higher bone turnover., 6 months|Changes in TRAP5b, Changes in TRAP5b compared between the groups. TRAP5b are measured in mIU/mL., 6 months|Changes in bone quality, Bone quality as measured by high resolution peripheral quantitative CT will be compared between groups., 6 months
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| Sponsor/Collaborators: |
Sponsor: Albert Einstein College of Medicine | Collaborators: Columbia University|University of Pittsburgh Medical Center|University of Utah|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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| Gender: |
ALL
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| Age: |
CHILD, ADULT, OLDER_ADULT
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| Phases: |
PHASE2|PHASE3
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| Enrollment: |
103
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-08-15
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| Completion Date: |
2026-08
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| Results First Posted: |
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| Last Update Posted: |
2024-10-15
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| Locations: |
Albert Einstein College of Medicine, Bronx, New York, 10461, United States|University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05918029
|
