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

September 25, 2017 updated by: University Hospital Inselspital, Berne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • BE
      • Bern, BE, Switzerland, 3008
        • University Hospital Bern Inselspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 111 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mg first
Receives MgCl2 first, MgCl2 and Bicarbonate in second phase
Device: Magnesium
Magnesium in dialysate increased
Device: Bicarbonate
Bicarbonate in dialysate increased
Experimental: Bicarbonate first
Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase
Device: Magnesium
Magnesium in dialysate increased
Device: Bicarbonate
Bicarbonate in dialysate increased

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
7 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Dominik Uehlinger, Prof Dr.med., University Hospital Inselspital, Berne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 26, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 293_15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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