Effervescent Calcium-Magnesium Citrate for End-Stage Renal Disease

Overseen By Miranda King, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Adrenocorticosteroids, Aluminum antacids

Disqualifiers: Bowel disease, Hypercalcemia, Hypophosphatemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 24 months

269 Participants Needed

What You Need to Know Before You Apply

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

Who Is on the Research Team?

Henry Quinones, MD

Principal Investigator

UTSW

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Baseline evaluation including medical history, side effect questionnaires, and initial tests

1 week

1 visit (in-person)

Treatment

Participants receive EffCaMgCit or CaAcS for two years with dose adjustments after three months

24 months

Visits every 3 months (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CaAcS
• Effervescent Calcium-Magnesium Citrate

Trial Overview 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.

How Is the Trial Designed?

Group I: EffCaMgCit Experimental Treatment 1 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: CaAcS Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+