FGF-23 and PTH in Hemodialysis Patients

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT04350944

Collaborator

(none)

Enrollment

Location

7.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Requiring Chronic Dialysis

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

FGF-23 and PTH During Hemodialysis Patients Under Consideration of Calcification Propensity - a Pilot Study

Actual Study Start Date :

Jan 14, 2020

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Aug 31, 2020

Outcome Measures

Primary Outcome Measures

Time course of FGF-23 and PTH levels during hemodialysis treatment. [1 day]
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).

Secondary Outcome Measures

T-50 calcification, sHPT parameters [1 day]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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