269 Participants Needed

Effervescent Calcium-Magnesium Citrate for End-Stage Renal Disease

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Overseen ByMiranda King, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

Research Team

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Henry Quinones, MD

Principal Investigator

UTSW

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.

Treatment Details

Interventions

  • CaAcS
  • Effervescent Calcium-Magnesium Citrate
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+