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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how altering magnesium levels in dialysis fluid can benefit people with kidney failure undergoing hemodialysis. The goal is to determine if increased magnesium can reduce the risk of death and heart problems, and possibly lessen muscle cramps. Researchers believe this simple change might improve patient well-being and lower healthcare costs. Individuals on hemodialysis who experience heart issues or frequent muscle cramps might be suitable candidates for this study.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance patient care and outcomes.

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.

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

Research has shown that increasing magnesium levels in dialysis fluid might be safe for patients. Studies suggest that patients on dialysis with higher magnesium levels in their treatment fluid could experience heart health benefits. However, this is still under investigation. Reports indicate that using fluid with low magnesium can lead to low magnesium levels in the blood, which is not ideal.

Previous research has included patients using fluid with magnesium levels similar to those in this trial. These studies did not find major safety issues. Participants using higher magnesium levels in their treatment fluid did not experience more side effects than those using lower levels. This suggests that different magnesium levels in the fluid are generally well-tolerated.

For those considering joining this study, this information may help clarify how the trial aims to measure the impact of magnesium on health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing higher versus lower hemodialysate magnesium levels for kidney failure because it could uncover optimal magnesium levels for dialysis patients. Unlike standard dialysis treatments that don't specifically focus on magnesium levels, this approach tests whether adjusting magnesium in the dialysate can improve patient outcomes. By fine-tuning magnesium levels, there is potential to enhance heart health, bone strength, and overall well-being for those undergoing dialysis, which could be a significant advancement over current practices.

What evidence suggests that increasing magnesium in the dialysate could be effective for patients on dialysis?

This trial will compare the effects of different magnesium levels in dialysis fluid for kidney failure patients. Research has shown that increasing magnesium in the dialysis fluid might be beneficial. Studies suggest that patients with low magnesium levels face a higher risk of heart problems and muscle cramps. Raising magnesium in the dialysis fluid may reduce these risks. Some research also indicates that this adjustment could improve overall survival and decrease hospital visits due to heart issues. Overall, adjusting magnesium levels in dialysis is considered a safe and potentially beneficial approach. ^{1 2 3 6 7}

Who Is on the Research Team?

Amit X Garg, PhD, MD

Principal Investigator

ICES, Lawson, London Health Sciences Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4455820/

Magnesium in chronic kidney disease Stages 3 and 4 and ... Twenty-five of the renal patients had been dialysed for a period of ∼23 months with a dialysis fluid containing 1.3 mEq/L (0.65 mmol/L) magnesium. Plasma ...

2. clinicaltrial.be clinicaltrial.be/en/details/4788?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Outcomes of a Higher vs. Lower Hemodialysate ... If the investigator is able to demonstrate that a higher dialysate magnesium concentration improves patient outcomes, this formulation can be ...

3. withpower.com withpower.com/trial/phase-kidney-diseases-3-2021-27df0

Higher vs. Lower Hemodialysate Magnesium for Kidney ... Studies suggest that increasing magnesium levels in dialysate for hemodialysis patients may be safe and could potentially offer cardiovascular benefits. However ...

4. ctv.veeva.com ctv.veeva.com/study/outcomes-of-a-higher-vs-lower-hemodialysate-magnesium-concentration-dial-mag-canada

Outcomes of a Higher vs. Lower Hemodialysate Magnesium ... Patients with low serum magnesium concentration have a higher risk of death, heart issues, muscle cramps and fractures. There are several ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6140564/

Magnesium Concentration in Dialysate: Is Higher Better? A total of 59 patients were randomized to either standard dialysate magnesium (0.5 mmol/L; 1 mEq/L) or to a high-dialysate magnesium (1 mmol/L; 2 mEq/L) for 4 ...

6. karger.com karger.com/bpu/article/45/1-3/173/329522/Magnesium-in-Chronic-Kidney-Disease-Should-We-Care

Magnesium in Chronic Kidney Disease: Should We Care? Use of low-Mg dialysate (0.25 mmol/L or 0.5 mEq/L) is a risk factor for hypomagnesaemia in patients on both haemodialysis (HD) and peritoneal ...

7. mdpi.com mdpi.com/2072-6643/15/7/1710

Magnesium in Kidney Function and Disease—Implications ... Ten studies were found in which the role of Mg and sex was evaluated in elderly patients with CKD in the last 10 years (2012–2022).