Effervescent Calcium-Magnesium Citrate for End-Stage Renal Disease

Recruiting in Palo Alto (17 mi)

Overseen byHenry Quinones, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

This trial is for adults over 21 with Chronic Kidney Disease Stage V on hemodialysis. It includes those with Type II diabetes and hypertension, and allows treatments for osteoporosis, kidney disease, hypertension or diabetes, and hormone therapies. Excluded are patients on steroids or aluminum antacids, with high serum magnesium levels or certain bowel diseases.

Inclusion Criteria

I am over 21, on hemodialysis, and have stage V chronic kidney disease.

I am taking medication for osteoporosis, chronic kidney disease, high blood pressure, diabetes, or hormone therapy.

People with Type II diabetes and high blood pressure can participate.

Exclusion Criteria

Your blood test shows a high level of magnesium.

I am not taking steroids or aluminum-based antacids.

I do not have bowel disease, high calcium, or low phosphate levels.

Participant Groups

The study tests effervescent calcium magnesium citrate (EffCaMgCit) against CaAcS in reducing cardiovascular risks in CKD Stage V patients by slowing calcification and cardiac issues. It also examines EffCaMgCit's effects on serum FGF23 levels, alkali load, bone turnover, and bone mineral density.

2Treatment groups

Experimental Treatment

Active Control

Group I: EffCaMgCitExperimental Treatment1 Intervention

Patients in the EffCaMgCit group will receive 45 meq (900 mg) Ca, 30 meq (365 mg) Mg, and 135 meq total citrate per day from 3 months to 2 years.

Group II: CaAcSActive Control1 Intervention

Patients in the CaAcS group will take 45 meq (900 mg) Ca and 45 meq acetate (without Mg or citrate) per day.