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.

Phase 1

• 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 System Organ Class: 100000004857; 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: LLT Classification code 10076410 Term: Chronic kidney disease stage 3 System Organ Class: 100000004857; 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 10020712 Term: Hyperphosphatemia System Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-002095-10-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 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

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