FGF-23 and PTH in Hemodialysis Patients

NCT04350944 | Completed

• 1 other identifier: FGF-23 and PTH during HD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

CKD; Hemodialysis; FGF 23; PTH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• T-50 calcification, sHPT parameters

  1 day

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \>18 years
• hemodialysis three times a week

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Three samples per patient and dialysis treatment will be drawn at the start, after 2 hours and at the end of dialysis. Blood samples will be collected from the dialysis machine. Blood is allowed to clot, serum and plasma will be separated by centrifugation and kept in aliquots (500µl) at -80° until further analysis. Parathyroid hormone (PTH), Serum calcium (sCa), phosphate (P), 25-hydroxy-vitamin D (25(OH)D) and 1,25 dihydroxy-vitamin D (1,25(OH)2D) will be determined by routine assays at the Department of Laboratory Medicine of the General Hospital of Vienna. FGF-23 will be determined by an iFGF-23 enzyme-linked immunosorbent assays (ELISA) of Biomedica and the T50-time will be measured by an nephelometer at the Calciscon Laboratory in Switzerland.

Study Officials

• Rainer Oberbauer, MD, PhD

  Head of the department of Nephrology and Dialysyis of the MUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Rainer Oberbauer, MD, PhD

Study Record Dates

• First Submitted: March 22, 2020
• First Posted: April 17, 2020
• Study Start: January 14, 2020
• Primary Completion: June 1, 2020
• Study Completion: August 31, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

AU (1)