Investigate the differences between treating Chronic Kidney Disease - Mineral and Bone Disorder with an iron-containing phosphate binder or a calcium-containing phosphate binder in patients with Kidney Disease.

Investigate the differences between treating Chronic Kidney Disease - Mineral and Bone Disorder with an iron-containing phosphate binder or a calcium-containing phosphate binder in Chronic Kidney Disease stage 3-5. - MIVI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002095-10-DK

Enrollment

Registered

2017-06-22

Start date

2017-09-13

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD), especially bone metabolism and blood vessel calcification MedDRA version: 20.0 Level: LLT Classification code 10076411 Term: Chronic kidney disease stage 4 System Organ Class: 100000004857 MedDRA version: 20.0 Level: LLT Classification code 10076412 Term: Chronic kidney disease stage 5

Interventions

Trade Name: Velphoro Product Name: Velphoro Pharmaceutical Form: Chewable tablet INN or Proposed INN: Sucroferric Oxyhydroxide CAS Numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 35-65 years old men and women with 3-5 CKD and requiring treatment for hyperphosphatemia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Inability to give informed consent, pregnancy, lactation, not radically treated cancer, alcohol abuse or drug abuse. Within three months: fractures, AMI, TCI, kidney transplant or parathyroidectomy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether treatment with an iron- or calcium-containing phosphate binder can affect differently the results from 18F-NaF PET/CT, bALP, osteocalcin, FGF23 og OPG/RANKL ratio. Differences in the stiffness of blood vessel assessed with applanation tonometry. Finally, we investigate changes in calcium score (TBR) and iron status;Secondary Objective: "not applicable";Primary end point(s): SUVmax og Ki;Timepoint(s) of evaluation of this end point: At the end of the trail, when all subjects have completed and the blood samples and PET/CT- scans are analyzed	—

Measure

Time frame

Main Objective: To investigate whether treatment with an iron- or calcium-containing phosphate binder can affect differently the results from 18F-NaF PET/CT, bALP, osteocalcin, FGF23 og OPG/RANKL ratio. Differences in the stiffness of blood vessel assessed with applanation tonometry. Finally, we investigate changes in calcium score (TBR) and iron status;Secondary Objective: "not applicable";Primary end point(s): SUVmax og Ki;Timepoint(s) of evaluation of this end point: At the end of the trail, when all subjects have completed and the blood samples and PET/CT- scans are analyzed

—

Secondary

Measure	Time frame
Secondary end point(s): Biomarkers: bALP, FGF23, osteocalcin and OPG/sRANKL ratio PET/CT: SUVmean, SUVpeak, SUVA50%, K1, K2, K3, K4 and calcium score (TBR). Iron parameters: p-iron, ferritin, transferrin, hepcidin Applanation tonometry: Heart Rate Variability (HRV), aPWV og AIx/central blood pressure (PVA) ;Timepoint(s) of evaluation of this end point: At the end of the trail, when all subjects have completed and the blood samples and PET/CT- scans are analyzed	—

Measure

Time frame

Secondary end point(s): Biomarkers: bALP, FGF23, osteocalcin and OPG/sRANKL ratio PET/CT: SUVmean, SUVpeak, SUVA50%, K1, K2, K3, K4 and calcium score (TBR). Iron parameters: p-iron, ferritin, transferrin, hepcidin Applanation tonometry: Heart Rate Variability (HRV), aPWV og AIx/central blood pressure (PVA) ;Timepoint(s) of evaluation of this end point: At the end of the trail, when all subjects have completed and the blood samples and PET/CT- scans are analyzed

—

Countries

Denmark

Contacts

Public ContactMarie Houmaa Vrist

Universitetsklinik for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro; Hospitalsenheden Vest

marvri@rm.dk004578436585

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026