Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial
Official title:
FGF-23 and PTH During Hemodialysis Patients Under Consideration of Calcification Propensity - a Pilot Study
Verified date | September 2021 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
In this pilot study the investigator will examine the levels of fibroblast growth factor (FGF-23) and parathyroid hormone (PTH) levels during hemodialysis therapy in 30 patients and assess the correlation between these parameters and the T-50 calcification propensity, as well as further parameters of secondary hyperparathyroidism (sHPT), like serum calcium (sCa), phosphate (P), 25-hydroxy-vitamin D (25(OH)D) and 1,25 dihydroxy-vitamin D (1,25(OH)2D). The investigator hypothesize that FGF-23 and PTH levels are at their highest at the beginning of dialysis and decrease during the treatment.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 31, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - >18 years - hemodialysis three times a week Exclusion Criteria: - Subject is currently enrolled or not yet completed at least 30 days since ending other investigational device or drug trial(s), or is receiving other investigational agent(s) - Pregnancy - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time course of FGF-23 and PTH levels during hemodialysis treatment. | This trial is designed to analyze the levels of fibroblast growth factor 23 and parathyroid hormone concentrations during hemodialysis treatment. Measurements will be performed at three timepoints during one single treatment session on one single treatment day. The first measurement will be performed at the beginning of dialysis (just after connecting the patient to the dialysis machine), the second after two hours of dialysis and the third at the end of the dialysis treatment (before disconnecting the patient from the machine). | 1 day | |
Secondary | T-50 calcification, sHPT parameters | T-50 calcification propensity and further parameters of secondary hyperparathyroidism (serum calcium, phosphate and vitamin D) as well as the correlation between these parameters. Measurements will be performed at the beginning of dialysis (just after connecting the patient to the dialysis machine). | 1 day |
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