Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease St… (NCT03565913) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V
United States269 participantsStarted 2017-01-22
Plain-language summary
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 can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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. Patients with Type II diabetes and hypertension will be allowed. Treatment with drugs for management of osteoporosis (bisphosphonate, teriparatide, or denosumab) or for chronic kidney disease, customary drugs for hypertension or diabetes, and exogenous estrogen or selective estrogen receptor modulators will be allowed.
Exclusion Criteria:
* Patients with serum Mg \> 3.65 mg/dL (3 meq/L) will be excluded (de Francisco, 2010). Also excluded from the study will be those with bowel disease, hypercalcemia, hypophosphatemia (serum P \< 2.5 mg/dL) and treatment with adrenocorticosteroids or aluminum-containing antacids or drugs.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing an effervescent calcium-magnesium citrate supplement in Stage 5 CKD patients — given how advanced my kidney disease is, is this type of intervention something that could be appropriate to discuss for my situation, and what risks might extra calcium or magnesium pose at this stage?
2The trial is measuring something called 'Serum T50 for CPP' as its main outcome — can you explain what that means in plain terms, and why it might matter for my long-term health with Stage 5 CKD?
3Since this is a Phase 2/3 trial, what does that tell us about how much is already known about both the safety and effectiveness of this supplement in people with kidney disease this advanced?
4The trial is listed as active but no longer recruiting — does that mean results might be available soon, and is there any emerging data from this study that could already influence the treatment decisions you'd recommend for me?
5Compared to whatever phosphate binders or other mineral management strategies I might already be on or considering, how would my doctor weigh the potential role of a calcium-magnesium citrate approach against standard care options for Stage 5 CKD?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum T50 for CPP
Timeframe: 24 months
Trial details
NCT IDNCT03565913
SponsorUniversity of Texas Southwestern Medical Center