The CPH-MBD Cohort
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHerlev Hospital
About this trial
Persons with chronic kidney disease (CKD) have a 3-fold increased risk of bone fracture and a 10-fold increased risk of cardiovascular disease than the general population. These increased risks are related to the disturbances in the mineral metabolism, and this clinical entity is termed Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD).
The overall aim of the present project is to explore factors that may predict or associate with the development of bone and cardiovascular disease in patients with CKD and hopefully provide insight into underlying mechanisms and pathophysiological pathways for future treatment and prevention.
In a sub study investigators aim to explore the calcium and phosphate balance in patients with CKD and describe how these associate with each other as well as with kidney function (eGFR).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
CKD stage 4-5nonD (eGFR ≤ 29 ml/min) according to KDIGO (Kidney Disease Improving Global Outcome) definition
Disqualifiers
None
Trial population
Participants will be recruited from the outpatient clinic, Department of Nephrology at Herlev Hospital. The outpatient clinic has approximately 1500 patients with CKD4-5nonD.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: CPH-MBD cohort
Group B: Detailed dietary assessment
Trial outcomes
Primary outcomes
1
Difference in time to first fracture between patients with normal bone turnover and low bone turnover based on bone turnover markers at baseline
Time frame
25 yearsSecondary outcomes
1
Time to fracture
All patients will be followed-up and fractures will be registered
Time frame
25 years2
Time to cardiovascular event
All patients will be followed-up and cardiovascular events will be registered
Time frame
25 years3
Progression in kidney disease
All patients will be followed-up and kidney function will be registered
Time frame
25 years4
Time to end-stage kidney disease
All patients will be followed-up and need for dialysis/kidney transplant will be registered.
Time frame
25 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Herlev Hospital
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution
Source ClinicalTrials.gov