Higher vs. Lower Hemodialysate Magnesium for Kidney Failure

Overseen By Amit X Garg, PhD, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Disqualifiers: Less than 15 patients

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

Compensation: Varies

Number of Visits: Unknown

Duration: Three to Four Years

25000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on changing the magnesium level in the dialysis solution, so it's best to ask the trial staff for guidance.

What data supports the effectiveness of this treatment for kidney failure?

Research suggests that increasing magnesium levels in the dialysate (the fluid used in dialysis) may help reduce the risk of death, especially from heart-related issues, in patients undergoing hemodialysis. Studies indicate that higher magnesium levels in the dialysate could be beneficial, as low magnesium levels are linked to higher mortality in these patients. ^{1 2 3 4 5}

Is it safe to use higher magnesium levels in dialysate for kidney failure patients?

Studies suggest that increasing magnesium levels in dialysate for hemodialysis patients may be safe and could potentially offer cardiovascular benefits. However, more detailed safety data is limited, and current guidelines do not routinely recommend higher magnesium concentrations. ^{1 2 3 4 6}

How does the treatment of higher vs. lower hemodialysate magnesium for kidney failure differ from other treatments?

This treatment is unique because it adjusts the magnesium concentration in the dialysis fluid to potentially improve patient outcomes, as higher magnesium levels in the blood have been linked to lower mortality in dialysis patients. Unlike standard treatments that use a lower magnesium concentration, this approach explores the benefits of increasing magnesium levels to enhance cardiovascular health and overall survival. ^{1 2 3 4 5}

What is the purpose of this trial?

Many patients on hemodialysis have low levels of magnesium. Magnesium is needed to keep the heart, kidneys, and other organs working properly. Patients with low serum magnesium concentration have a higher risk of death, heart issues, muscle cramps and fractures. There are several reasons why patients on dialysis have low levels of magnesium-these include poor diet, medication interference, and the dialysis procedure itself, which leaches small amounts of magnesium from the blood during each treatment. One way to make sure that patients on dialysis are getting enough magnesium is to increase its concentration in the dialysate. The investigator would like to do a randomized controlled trial to determine the effect of increasing the concentration of magnesium in the dialysate on the risk of people on dialysis dying or being admitted to the hospital due to heart issues. The investigator thinks increasing the magnesium in the dialysate will help patients live longer, have fewer hospitalisations related to heart disease and patients may also experience less cramping associated with dialysis. This simple adjustment to the dialysis procedure can be done at little cost and may even reduce overall healthcare costs. If the investigator can show that increasing magnesium in the dialysate improves patients' health, then it could become the standard of care for all patients on dialysis.

Research Team

Amit X Garg, PhD, MD

Principal Investigator

ICES, Lawson, London Health Sciences Centre

Eligibility Criteria

This trial is for patients undergoing in-center maintenance hemodialysis at facilities that treat at least 15 such patients. The facility's medical director must agree to use the assigned magnesium protocol throughout the study. Centers with fewer than 15 patients on conventional in-center hemodialysis are excluded.

Inclusion Criteria

My dialysis center treats at least 15 patients with in-center hemodialysis.

My dialysis center's director agrees to follow the trial's magnesium protocol.

Exclusion Criteria

My dialysis center treats fewer than 15 patients with standard in-center hemodialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either higher or lower dialysate magnesium concentration as part of their routine hemodialysis treatment

Three to Four Years

Follow-up

Participants are monitored for cardiovascular-related hospitalization and all-cause mortality using routinely collected data

Three to Four Years

Treatment Details

Interventions

• Dialysate magnesium formulation of ≤1.0 mEq/L (≤0.5 mmol/L)
• Dialysate magnesium formulation of 1.5 mEq/L (0.75 mmol/L)

Trial Overview The study is testing two different concentrations of magnesium in dialysate solutions used during hemodialysis: one lower (≤1.0 mEq/L) and one higher (1.5 mEq/L). It aims to see if a higher concentration can reduce deaths, heart-related hospitalizations, and muscle cramps associated with dialysis.

Participant Groups

Group I: Higher dialysate magnesium Experimental Treatment 1 Intervention

Group II: Lower dialysate magnesium Active Control 1 Intervention

Who Is Running the Clinical Trial?

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

ICES

Industry Sponsor

Trials

6

Recruited

534,000+

ICES

Collaborator

Trials

4

Recruited

327,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Consequences of Supraphysiological Dialysate Magnesium on Arterial Stiffness, Hemodynamic Profile, and Endothelial Function in Hemodialysis: A Randomized Crossover Study Followed by a Non-Controlled Follow-Up Phase. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Routine hemodialysis induces a decline in plasma magnesium concentration in most patients: a prospective observational cohort study. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Reduced Mortality in Maintenance Haemodialysis Patients on High versus Low Dialysate Magnesium: A Pilot Study. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Magnesium in chronic haemodialysis (MAGIC-HD): a study protocol for a randomised controlled trial to determine feasibility and safety of using increased dialysate magnesium concentrations to increase plasma magnesium concentrations in people treated with haemodialysis. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

[Mass transfer of magnesium in hemodialysis]. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Acute effects of different concentrations of dialysate magnesium during high-efficiency dialysis. [2019]