Clinical trial NCT04350944: FGF-23 and PTH in Hemodialysis Patients
Official title: FGF-23 and PTH During Hemodialysis Patients Under Consideration of Calcification Propensity - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: CKD
Hemodialysis
FGF 23
PTH
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 adult patients with chronic kidney disease receiving hemodialysis treatment at the Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis. All patients are on a thrice-weekly dialysis schedule.

Brief summary: 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.

Detailed description: Background: The development of sHPT in hemodialysis patients is a common complication which induces an increase in calcification and atherosclerosis. Elevated FGF-23 levels are already found in early stages of chronic kidney disease (CKD) and it has been shown that high FGF-23 levels are associated with the development of cardiovascular disease and increased overall mortality.

Method: In this pilot study a total number of 30 patients on maintenance haemodialysis will be enrolled. The investigator will examine the course of FGF-23 and PTH levels during a single hemodialysis session. In addition, the T-50 time, a novel non-traditional cardiovascular risk factor as well as further parameters of sHPT, such as serum calcium (sCa), phosphate (P), 25-hydroxy-vitamin D (25(OH)D) and 1,25 dihydroxy-vitamin D (1,25(OH)2D) will be assessed.

Hypothesis and specific aims: The major end point of the study is the level of FGF-23 and PTH at three points during hemodialysis treatment. As secondary end points the T-50 calcification propensity and further parameters of sHPT, as well as the correlation between these parameters will be measured.

Hemodialysis is classified as a kidney replacement therapy and FGF-23 and PTH are partly metabolized and excreted by the kidneys. Based on this the investigator hypothesize that FGF-23 and PTH levels are at their highest at the beginning of dialysis and decrease during the treatment.

Eligibility criteria: 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

Primary outcomes:
measure: Time course of FGF-23 and PTH levels during hemodialysis treatment.
timeFrame: 1 day
Secondary outcomes:
measure: T-50 calcification, sHPT parameters
timeFrame: 1 day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Head of the department of Nephrology and Dialysyis of the MUV
name: Rainer Oberbauer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: