FGF-23 and PTH in Hemodialysis Patients

NCT ID: NCT04350944

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2020-08-31

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.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Rainer Oberbauer

Univ.-Prof. Rainer Oberbauer, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rainer Oberbauer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Head of the department of Nephrology and Dialysyis of the MUV

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

FGF-23 and PTH during HD

Identifier Type: -

Identifier Source: org_study_id