Overview

Effect of Dietary Magnesium Supplementation vs. Dapagliflozin in Patients With Diabetic Kidney Disease (DKD)

Status:
Not yet recruiting

Trial end date:
2022-08-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

University of Texas Southwestern Medical Center

Treatments:

2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Dapagliflozin