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NCT03565913Active, not recruitingPhase 2/3

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

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
269 (actual)
First submitted
18 May 2018
Start date
22 Jan 2017
Primary completion date
1 Dec 2026
Lead sponsor
University of Texas Southwestern Medical Center
NCT number
NCT03565913

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 269
  • From 22 Jan 2017 to the primary completion date, 1 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
DaVita Dialysis Centers
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.