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Calcium and Magnesium Supplement

Effervescent Calcium-Magnesium Citrate for End-Stage Renal Disease

Phase 2 & 3
Recruiting
Led By Henry Quinones, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult subjects (> 21 years of age, any cause of CKD) of either gender of any ethnicity with CKD Stage V on hemodialysis will be recruited
Be older than 18 years old
Must not have
Patients under treatment with adrenocorticosteroids or aluminum-containing antacids or drugs will be excluded
Patients with bowel disease, hypercalcemia, hypophosphatemia (serum P < 2.5 mg/dL) will be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will explore whether effervescent calcium magnesium citrate (EffCaMgCit) can help people with end stage renal disease on hemodialysis by reducing the formation of calciprotein particles (CPP), which can cause heart and artery problems.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly stated here, potential side effects may include imbalances in electrolytes like calcium or magnesium leading to muscle weakness or arrhythmias; gastrointestinal symptoms such as bloating; and changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 21, on hemodialysis, and have stage V chronic kidney disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking steroids or aluminum-based antacids.
Select...
I do not have bowel disease, high calcium, or low phosphate levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Serum T50 for CPP
Secondary study objectives
Control of hyperphosphatemia and serum FGF23
Intracellular muscle magnesium
Parathyroid function and bone turnover

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,080 Previous Clinical Trials
1,056,044 Total Patients Enrolled
Henry Quinones, MDPrincipal InvestigatorUTSW

Media Library

Effervescent Calcium-Magnesium Citrate (Calcium and Magnesium Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03565913 — Phase 2 & 3
Renal disease Research Study Groups: EffCaMgCit, CaAcS
Renal disease Clinical Trial 2023: Effervescent Calcium-Magnesium Citrate Highlights & Side Effects. Trial Name: NCT03565913 — Phase 2 & 3
Effervescent Calcium-Magnesium Citrate (Calcium and Magnesium Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03565913 — Phase 2 & 3
~3 spots leftby Dec 2024
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