Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease

Completed · Not applicable

Conditions studied: Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Diseases

In brief

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.

Key facts

Study ID

NCT04019379

Run by

University of Minnesota

People needed

3

Starts

2020-08-31

Expected to finish

2023-01-30

Last updated by the study team

2024-09-19

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana CTSI CRC — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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