Chronic Kidney Diseases Clinical Trial
Official title:
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
Verified date | January 2023 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot study aims to develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease.
Status | Active, not recruiting |
Enrollment | 3 |
Est. completion date | December 1, 2023 |
Est. primary completion date | October 28, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility | Inclusion Criteria: - Men or women, ages 30-75 years old, any race or ethnicity - Moderate chronic kidney disease - Female subjects must be postmenopausal (>12 months since last menstrual period), surgically sterile, or confirmed not pregnant by pregnancy test - Must be on stable doses of medications (except those noted in exclusion criteria) for at least 4 weeks prior to the study - Willing to discontinue nutritional supplements (e.g. vitamin D, calcium, multivitamin/minerals, or others) upon enrollment until completion of the study - Adequate vitamin D status defined as serum 25D > 20 ng/mL Exclusion Criteria: - Plans to initiate dialysis within 6 months - Hypercalcemia defined as serum calcium >10.5 mg/dL within past 3 months - Hyperkalemia defined as serum potassium >5.5 mg/dL within past 3 months - Hyperphosphatemia defined as serum phosphate >5.5 mg/dL within past 3 months - Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, or bariatric surgery - Serious, uncontrolled underlying systemic disease including diabetes, lupus, hypertension - Pregnant or breastfeeding - Prescribed a phosphate binder medication, calcitriol, vitamin D analogs, calcimimetics, parathyroid hormone analogues, and other medications that may alter Ca and P metabolism within past 30 days |
Country | Name | City | State |
---|---|---|---|
United States | Indiana CTSI CRC | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fractional calcium absorption | Determined by kinetic modeling of serum and urine Ca-44 isotope after oral and IV isotope administrations | 48 hours | |
Primary | Fractional phosphorus absorption | Determined by kinetic modeling of serum and urine P-33 isotope after oral and IV isotope administrations | 48 hours | |
Primary | Calcium balance | Determined by analysis of calcium content in complete 24-hour urine and stool collections, subtracted from the diet calcium content consumed. | 2 weeks | |
Primary | Phosphorus balance | Determined by analysis of phosphorus content in complete 24-hour urine and stool collections, subtracted from the diet phosphorus content consumed. | 2 weeks | |
Primary | Calcium kinetic model | Determined by kinetic modeling of serum, urine, and fecal Ca-44 isotope after oral and IV isotope administrations | 2 weeks | |
Primary | Phosphorus kinetic model | Determined by kinetic modeling of serum, urine, and fecal P-33 isotope after oral and IV isotope administrations | 2 weeks | |
Secondary | Creatinine clearance rate | 24 hours, Day 8 | ||
Secondary | Plasma fibroblast growth factor 23 concentration | Day 1, Day 8 | ||
Secondary | Plasma parathyroid hormone concentration | Day 1, Day 8 | ||
Secondary | Plasma 1,25-dihydroxyvitamin D concentration | Day 1, Day 8 | ||
Secondary | Plasma phosphate concentration | Day 1, Day 8 | ||
Secondary | Plasma calcium concentration | Day 1, Day 8 |
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