BicMag Study - Improving Mineral Buffering Capacity in Dialysis Patients

N/ANot Yet RecruitingNCT07663279

Elisabethinen Hospital91 enrolled

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

D-StandardOTHER

Center's standard dialysate containing 32 mmol/L bicarbonate and 0.5 mmol/L magnesium

D-BicOTHER

Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium held at 0.5 mmol/L

D-MagOTHER

Dialysate magnesium increased to 1.0 mmol/L; dialysate bicarbonate held at 32 mmol/L

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Calciprotein crystallization time (T50) as a measure of mineral buffering capacity

Intra-individual difference in T50 between the combination dialysate (D-BicMag) and each of the single-intervention dialysates (D-Bic and D-Mag)

Time frame: 3 weeks (per study phase)

Secondary Outcomes

Endogenous calciprotein particle (CPP) levels

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)

Time frame: 3 weeks (per study phase)

Data from ClinicalTrials.gov

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