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 treated with dialysis .

Phase 1

• Conditions: Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD), especially bone metabolism and blood vessel calcification; MedDRA version: 20.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.0 Level: HLT Classification code 10027425 Term: Metabolic bone disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0 Level: PT Classification code 10078095 Term: Chronic kidney disease-mineral and bone disorder System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0 Level: LLT Classification code 10012347 Term: Dependence on renal dialysis System Organ Class: 100000004869; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-002096-26-DK
• Lead Sponsor: niversitetsklinik for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro; Hospitalsenheden Vest

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-22
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

35-65 years old hemodialysis patients
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Biomarkers: bALP, FGF23, osteocalcin and OPG/sRANKL ratio<br> PET/CT: SUVmean, SUVpeak, SUVA50%, K1, K2, K3, K4 and calcium score (TBR).<br> Iron parameters: p-iron, ferritin, transferrin.<br> Applanation tonometry: Heart Rate Variability (HRV), aPWV og AIx/central blood pressure (PVA)<br> ;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