EUCTR2016-005160-34-DK
Active, not recruiting
Phase 1
18F-NaF PET/CT in combination with biomarkers for the classification of renal osteodystrophy in chronic kidney disease
niversitetsklinikken for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro, Hospitalsenheden Vest0 sites40 target enrollmentDecember 23, 2016
ConditionsChronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD), especially renal osteodystofi.MedDRA version: 20.0 Level: LLT Classification code 10065404 Term: Combined positron emission tomogram and computerised tomogram System Organ Class: 10022891 - InvestigationsMedDRA version: 20.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - InvestigationsMedDRA version: 20.0 Level: LLT Classification code 10066622 Term: Chronic hemodialysis System Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD), especially renal osteodystofi.
- Sponsor
- niversitetsklinikken for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro, Hospitalsenheden Vest
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 30\-80 years
- •Chronic hemodialysis
- •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 20
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 20
Exclusion Criteria
- •Medical treatment with systemic corticosteroid
- •Inability to give informed consent
- •Pregnancy and lactation
- •Not radically treated cancer disease
- •Alcohol or drugs abuse
- •Within three months: bone fracture, AMI or TCI, parathyroidektomi or kidney transplantation
Outcomes
Primary Outcomes
Not specified
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