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Completed

NCT Number: NCT02621762

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

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.

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Key information

Conditions

End Stage Renal Failure on Dialysis Calcinosis Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Calcification

Age range

18 year–111 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bern Inselspital

Bern, Canton of Bern, 3008, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium

Device

Magnesium in dialysate increased

Bicarbonate

Device

Bicarbonate in dialysate increased

Primary outcomes

  1. Effect of treatment on serum calcification propensity, measured by T50

    Time frame: 7 weeks

    T50: Transformation time of primary calciprotein particles to secondary calciprotein particles (Pasch et al, 2012)

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: BicMag

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2015
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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