drugset / Trial / NCT03565913

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

NCT03565913 ↗

Phase 2/3 Active not recruiting 269 enrolled University of Texas Southwestern Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2017-01-22
Primary completion
2026-12-01
Completion
2026-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject EffCaMgCit Unknown 10 meq —
Subject EffCaMgCit Unknown 15 meq —
Subject EffCaMgCit Unknown 45 meq —