Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum

Study Overview
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Brief Summary
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The study aims to determine the effect size of magnesium and bicarbonate supplementation as a basis for future randomized controlled trials aiming at the T50-guided improvement of hard clinical endpoints in dialysis patients.

Official Title
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Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum

Conditions
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End Stage Renal Failure on Dialysis, Vascular Calcification

Intervention / Treatment
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* Device: Magnesium
* Device: Bicarbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female hemodialysis patients ≥ 18 years of age Negative pregnancy test of female patients in child-bearing age The patients have to be able to understand the character and the individual impact of the clinical study and they have to give written informed consent to participate in the study Start of chronic hemodialysis treatment ≥ 3 months ago HCO3- in venous plasma ≤23 mmol/L before the start of the last dialysis of the week Magnesium in venous plasma ≤ 1.45 mmol/L before the start of the first dialysis of the week T50 ≥ 200 minutes. Exclusion Criteria: Pregnant or lactating subjects. A blood pregnancy test will be performed at the screening visit in female patients of childbearing age. History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 111 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mg first<br>Receives MgCl2 first, MgCl2 and Bicarbonate in second phase | Device: Magnesium<br>* Magnesium in dialysate increased<br>Device: Bicarbonate<br>* Bicarbonate in dialysate increased<br>|
| Experimental: Bicarbonate first<br>Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase | Device: Magnesium<br>* Magnesium in dialysate increased<br>Device: Bicarbonate<br>* Bicarbonate in dialysate increased<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of treatment on serum calcification propensity, measured by T50 | T50: Transformation time of primary calciprotein particles to secondary calciprotein particles (Pasch et al, 2012) | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events |  | 7 weeks |