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?

This trial tests a new treatment called Effervescent Calcium-Magnesium Citrate (EffCaMgCit) for individuals with end-stage renal disease undergoing hemodialysis. The goal is to determine if this treatment can reduce heart and blood vessel issues by slowing harmful particle formation in the blood. The trial will also compare EffCaMgCit to another treatment, assessing heart health and bone strength. Individuals with end-stage kidney disease on hemodialysis, who may have type 2 diabetes or high blood pressure, might be suitable candidates for this trial. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Effervescent Calcium-Magnesium Citrate (EffCaMgCit) is generally safe for people with end-stage kidney disease. Research suggests that EffCaMgCit can help prevent harmful particles from forming in the blood, potentially lowering the risk of heart and blood vessel issues. It also appears to reduce certain hormones and provides beneficial magnesium and alkali. These effects are promising and unique.

Previous patients have not reported any major safety concerns with EffCaMgCit. However, like any treatment, some side effects may occur. Currently in Phase 2 and Phase 3 trials, EffCaMgCit has already passed initial safety tests and is now being studied for effectiveness and further safety evaluations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for end-stage renal disease?

Unlike the standard treatments for end-stage renal disease, which often include calcium acetate without additional elements, Effervescent Calcium-Magnesium Citrate (EffCaMgCit) introduces a unique combination of calcium, magnesium, and citrate. This combination not only provides essential minerals but also the citrate component, which can help reduce the risk of vascular calcification, a common complication. Researchers are excited about EffCaMgCit because it offers a potential dual benefit of supplementing necessary minerals while potentially preventing some of the secondary issues associated with current treatments.

What evidence suggests that EffCaMgCit might be an effective treatment for end-stage renal disease?

Research has shown that Effervescent Calcium-Magnesium Citrate (EffCaMgCit), which participants in this trial may receive, might benefit individuals with severe kidney disease by reducing harmful particles in the blood. This treatment may also lower parathyroid hormone (PTH) levels, which are linked to bone and heart problems. Studies suggest that EffCaMgCit can provide magnesium and alkali, potentially benefiting heart health. Higher magnesium levels in the blood have been associated with a lower risk of heart issues and even death in patients on dialysis. Overall, these findings suggest that EffCaMgCit could help manage heart and bone health in people with severe kidney disease. ^{1 2 3 4 6}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03565913

Study Details | NCT03565913 | Potential Therapeutic Role ... Study Plan · 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.

2. withpower.com withpower.com/trial/phase-2-and-3-renal-insufficiency-chronic-2017-d1567

Effervescent Calcium-Magnesium Citrate for End-Stage ... ... Calcium-Magnesium Citrate will have tolerable side effects & efficacy for patients with Chronic Kidney Disease and Renal disease. Learn more about the study.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30465137/

Control of metabolic predisposition to cardiovascular ... Conclusions: In Stage 5D, EffCaMgCit inhibited formation of CPP, suppressed PTH, and conferred magnesium and alkali loads. These effects were ...

4. link.springer.com link.springer.com/article/10.1007/s40620-018-0559-2

a feasibility study | Journal of Nephrology Turning to another potentially beneficial effect of EffCaMgCit, a higher serum bicarbonate associated with a lower incidence of end stage renal ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2021/11120/associations_between_the_serum_magnesium_and.3.aspx

Associations between the serum magnesium and all-cause ... Our results show that hypomagnesemia is significantly associated with cardiovascular and all-cause mortality in maintenance HD patients.

6. researchgate.net researchgate.net/publication/356176317_Associations_between_the_serum_magnesium_and_all-cause_or_cardiovascular_mortality_in_chronic_kidney_disease_and_end-stage_renal_disease_patients_A_meta-analysis

Associations between the serum magnesium and all-cause ... The results showed that after multivariable adjusted, hypomagnesemia was significant associated with the risk of all-cause mortality in patients with CKD and ...