Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney D… (NCT04019379) | Clinical Trial Compass
CompletedNot Applicable
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
United States3 participantsStarted 2020-08-31
Plain-language summary
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.
Who can participate
Age range30 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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