Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
BicMag
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedSeptember 26, 2017
September 1, 2017
5 months
November 26, 2015
September 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of participants with treatment-related adverse events
7 weeks
Study Arms (2)
Mg first
EXPERIMENTALReceives MgCl2 first, MgCl2 and Bicarbonate in second phase
Bicarbonate first
EXPERIMENTALReceives Bicarbonate first, MgCl2 and Bicarbonate in second phase
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Bern Inselspital
Bern, Canton of Bern, 3008, Switzerland
Related Publications (1)
Pasch A, Farese S, Graber S, Wald J, Richtering W, Floege J, Jahnen-Dechent W. Nanoparticle-based test measures overall propensity for calcification in serum. J Am Soc Nephrol. 2012 Oct;23(10):1744-52. doi: 10.1681/ASN.2012030240. Epub 2012 Sep 6.
PMID: 22956818BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominik Uehlinger, Prof Dr.med.
Insel Gruppe AG, University Hospital Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2015
First Posted
December 3, 2015
Study Start
December 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
September 26, 2017
Record last verified: 2017-09