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

StatusActive, Not Recruiting
PhasePhase 2/3
Started2017-01-22
View on ClinicalTrials.gov ↗

Amendment history

2026-06-01
Study Status, Oversight v11
Primary completion date2025-12-31→2026-12-01
Completion date2025-12-31→2026-12-18
2025-05-08
Study Status, Oversight v10
Primary completion date2025-03-31→2025-12-31
Completion date2025-03-31→2025-12-31
2025-01-29
Study Status v9
Primary completion date2024-12-31→2025-03-31
2024-11-05
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 245→confirmed 269
Study sitesdetails revised at 1 of 1 site
2023-10-11
Active, Not Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2023-03-31→2024-12-31
Completion date2024-03-31→2025-03-31
Enrollment target243→245
Study sitesdetails revised at 1 of 1 site
Show 6 earlier versions
2023-01-20
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 225→confirmed 243
Study sitesdetails revised at 1 of 1 site
2022-02-09
Active, Not Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2022-03-31→2023-03-31
Completion date2023-03-31→2024-03-31
Enrollment target125→225
Study sitesdetails revised at 1 of 1 site
2021-02-04
Study Status, Sponsor/Collaborators v4
Primary completion date2021-01-22→2022-03-31
Completion date2022-01-22→2023-03-31
2020-05-11
Recruiting→Active, Not Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Design, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2020-01-22→2021-01-22
Completion date2020-01-22→2022-01-22
Enrollment targetestimated 150→confirmed 125
Study sitesdetails revised at 1 of 1 site
2019-05-22
Study Status v2
Primary completion date2019-01-22→2020-01-22
2018-06-28
Study Status, Study Description v1
Study description+15 characters
[...] cardioprotective independently of effects on CPP formation WeThe Investigators anticipate that serum FGF23 would be lower and serum Klotho would be higher on EffCaMgCit
2018-06-11
Original filing
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
Trial Details
NCT Number NCT03565913
Lead Sponsor University of Texas Southwestern Medical Center
Conditions CKD Stage 5
Enrollment 269 participants
Start Date 2017-01-22
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-18 (estimated)
Updated on ClinicalTrials.gov 2026-06-03