BicMag Study - Improving Mineral Buffering Capacity in Dialysis Patients

June 17, 2026 updated by: Prim. Priv. Doz. Dr. Daniel Cejka, Elisabethinen Hospital
The BicMag study is a prospective, randomized, controlled cross-over study that aims to examine the potential additive effect of a dialysate enriched with both bicarbonate and magnesium on mineral buffering capacity in the blood of chronic hemodialysis patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

We hypothesize that simultaneously increasing bicarbonate and magnesium concentrations in the dialysate will enhance mineral buffering capacity more effectively than either intervention alone. Ninty-one chronic hemodialysis patients will be enrolled in this randomized, controlled, cross-over study. Using a balanced Latin square design, participants will undergo four sequential 3-week treatment phases with the following dialysates:

  • D-Standard: 32 mmol/L bicarbonate, 0.5 mmol/L magnesium
  • D-Bic: 37 mmol/L bicarbonate, 0.5 mmol/L magnesium
  • D-Mag: 32 mmol/L bicarbonate, 1 mmol/L magnesium
  • D-BicMag: 37 mmol/L bicarbonate, 1 mmol/L magnesium. The primary endpoint is calciprotein crystallization time (T50); the secondary endpoint is serum levels of endogenous calciprotein particles.

Study Type

Interventional

Enrollment (Estimated)

91

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Prevalent patients (≥ 3 months) treated with thrice weekly hemodialysis or hemodiafiltration
  • Dialysate calcium of 1.25 mmol/l

Exclusion Criteria:

  • Inability to provide informed consent
  • Currently participating in another investigational device or drug study or non-interventional study
  • Dialysate calcium other than 1.25 mmol/l
  • Parathyroidectomy planned during the study
  • Elective living-donor kidney transplant scheduled during the study period
  • Therapy with bisphosphonates within the past 12 months or denosumab within the past 6 months
  • Pregnant or nursing (lactating) women

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dialysate composition adjustment
Four sequential 3-week treatment periods with different dialysate compositions (D-Standard, D-Bic, D-Mag, D-BicMag) in a crossover design.
Other: D-Standard
Center's standard dialysate containing 32 mmol/L bicarbonate and 0.5 mmol/L magnesium
Other: D-Bic
Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium held at 0.5 mmol/L
Other: D-Mag
Dialysate magnesium increased to 1.0 mmol/L; dialysate bicarbonate held at 32 mmol/L
Other: D-BicMag
Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium increased to 1.0 mmol/L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calciprotein crystallization time (T50) as a measure of mineral buffering capacity
Time Frame: 3 weeks (per study phase)
Intra-individual difference in T50 between the combination dialysate (D-BicMag) and each of the single-intervention dialysates (D-Bic and D-Mag)
3 weeks (per study phase)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endogenous calciprotein particle (CPP) levels
Time Frame: 3 weeks (per study phase)
Intra-individual difference in endogenous calciprotein particle levels between the combination dialysate (D-BicMag) and each of the single-intervention dialysates (D-Bic and D-Mag)
3 weeks (per study phase)

Collaborators and Investigators

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

Sponsor

Elisabethinen Hospital

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 (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BicMag-HD-T50

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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