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Clinical Trial Summary

This is a prospective, randomized double blind placebo controlled parallel group trial to assess the effect of Effervescent calcium magnesium citrate (EffCaMgCitrate) and dapagliflozin on surrogate markers of kidney and cardiovascular health in patients with stage 3b-4 Chronic Kidney Disease (CKD). Randomization: 1. Placebo EffCaMgCitrate + Placebo Dapagliflozin BID (bis in die / two times) 2. EffCaMgCitrate 480mg Mg (total dosage per day) + Placebo Dapagliflozin BID 3. Dapagliflozin 10mg (total dosage per day) + Placebo EffCaMgCitrate BID This study includes three clinic in person visits and weekly telephone visits for 24 weeks. 1. Recruit 30 patients with CKD stages 3b-4 and randomize them in double-blind fashion to either placebo, CaMgcitrate 480mg Mg or dapagliflozin 10mg twice daily for 24 weeks 2. Determine the effect of interventions on the primary outcome variable serum klotho measured by immunoprecipitation-immunoblot 3. Determine the effect of interventions on magnesium.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05033054
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact Robert Toto, MD
Phone 214-645-8267
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date September 2021
Completion date August 2022

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