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

End Stage Renal Failure on Dialysis Clinical Trial

— BicMag  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621762
• Other study ID #: 293_15
• Status: Completed
• Phase: N/A
• First received: November 26, 2015
• Last updated: September 25, 2017
• Start date: December 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2017
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 111 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Vascular Calcification

Intervention

Device:
• Magnesium
Magnesium in dialysate increased
• Bicarbonate
Bicarbonate in dialysate increased

Locations

Country	Name	City	State
Switzerland	University Hospital Bern Inselspital	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Pasch A, Farese S, Gräber 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. Epub 2012 Sep 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with treatment-related adverse events		7 weeks