BicMag Study - Improving Mineral Buffering Capacity in Dialysis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D-Standard, D-Bic, D-Mag, D-BicMag.
- Who it may be relevant to
- Registry conditions: End Stage Renal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- 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
Primary outcome measures
- Calciprotein crystallization time (T50) as a measure of mineral buffering capacity [Time frame: 3 weeks (per study phase)]
Secondary outcome measures (1)
- Endogenous calciprotein particle (CPP) levels [Time frame: 3 weeks (per study phase)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07663279 · BicMag-HD-T50