BicMag Study - Improving Mineral Buffering Capacity in Dialysis Patients

NCT07663279 | Not Yet Recruiting

• 1 other identifier: BicMag-HD-T50
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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)

  3 weeks (per study phase)

Secondary Outcomes (1)

• Endogenous calciprotein particle (CPP) levels

  3 weeks (per study phase)

Study Arms (1)

dialysate composition adjustment

EXPERIMENTAL

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; Other: D-Bic; Other: D-Mag; Other: D-BicMag

Interventions

D-Standard OTHER

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

dialysate composition adjustment

D-Bic OTHER

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

dialysate composition adjustment

D-Mag OTHER

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

dialysate composition adjustment

D-BicMag OTHER

Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium increased to 1.0 mmol/L

dialysate composition adjustment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elisabethinen Hospital: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nephrology

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 23, 2026

Record last verified: 2026-06