Overview

Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V

Status:
Active, not recruiting
Trial end date:
2023-03-31
Target enrollment:
0
Participant gender:
All
Summary
The Investigators plan to conduct a long-term trial to explore therapeutic implications of effervescent calcium magnesium citrate (EffCaMgCit) in CKD Stage V (end stage renal disease on hemodialysis). The Investigators will test the hypothesis that EffCaMgCit would retard the formation of calciprotein particles (CPP) in CKD Stage V, thereby reducing the degree of coronary artery and peripheral artery calcification and cardiac hypertrophy-fibrosis. Aim 1. To compare cardiovascular risk of EffCaMgCit versus CaAcS in CKD Stage V Aim 2. To show that EffCaMgCit reduces putative serum FGF23, and increases beneficial alkali load Aim 3. To compare parameters of bone turnover and bone mineral density (BMD) between EffCaMgCit and CaAcS groups
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Treatments:
Calcium
Calcium acetate
Calcium, Dietary
Citric Acid
Magnesium citrate
Criteria
Inclusion Criteria:

- Adult subjects (> 21 years of age, any cause of CKD) of either gender of any ethnicity
with CKD Stage V on hemodialysis will be recruited. Patients with Type II diabetes and
hypertension will be allowed. Treatment with drugs for management of osteoporosis
(bisphosphonate, teriparatide, or denosumab) or for chronic kidney disease, customary
drugs for hypertension or diabetes, and exogenous estrogen or selective estrogen
receptor modulators will be allowed.

Exclusion Criteria:

- Patients with serum Mg > 3.65 mg/dL (3 meq/L) will be excluded (de Francisco, 2010).
Also excluded from the study will be those with bowel disease, hypercalcemia,
hypophosphatemia (serum P < 2.5 mg/dL) and treatment with adrenocorticosteroids or
aluminum-containing antacids or drugs.