The Longitudinal PTH-Study

NCT03464149 | Completed

• 1 other identifier: The Longitudinal PTH-Study
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The main study aim is to quantify the agreement between the analytical results provided by two third generation and two second generation Parathyroid hormone (PTH) assays. The primary comparison will be performed between the second-generation PTH assay"Intact PTH assay" from Siemens Healthcare Diagnostics Inc. and the third-generation PTH assay "biointact (1-84)" from Roche Diagnostics in terms of a Bland-Altman analysis. Several studies have evaluated the correlation between various PTH assays at a single time-point, but no previous study has tested the hypothesis that longitudinal changes in PTH levels, which are important for making treatment decisions, can be monitored by several PTH assays alike. To this aim, the key secondary objective is to analyze the longitudinal variance in PTH over the course of 1 year, using each of two assays of the second and third generations, respectively. Other secondary objectives include determining changes in serum phosphate, serum calcium, fibroblast growth factor 23 (FGF23), with respect to treatment decisions. For clinical applicability of the results to be obtained here, an important goal of the present study will be not to influence treatment decisions, which will remain independent of the study investigators, at the full responsibility of the hemodialysis physicians. At every quarterly blood draw over the course of one year, the investigators will freeze the serum from 100 patients, and at the end of 4 quarters the investigators will analyze PTH-levels using the following assays: Intact Parathyroid Hormone (Advia Centaur, Siemens Healthcare), PTH-Intact (Cobas, Roche), PTH (1-84) - The agreement between the PTH assays will be analyzed at baseline, as well as at the subsequent quarterly evaluation time-points by Bland-Altman analysis and complemented by Passing-Bablok regression. The longitudinal changes in PTH will be displayed graphically and analyzed by estimating the within-patient variance across time, the between patient variance at each time-point as well as effects on the mean log-PTH level due to course of disease and therapeutic interventions from a linear mixed model.

Conditions

CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder; Secondary Hyperparathyroidism; Kidney Replacement

Outcome Measures

Primary Outcomes (1)

• Longitudinal change in PTH levels measured in [pg/ml]

  PTH levels as measured by the second and third generation assays

  Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)

Secondary Outcomes (4)

• Longitudinal within-patient change of PTH levels in [pg/ml]

  Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)

• Serum Calcium levels

  Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)

• Serum Phosphate levels

  Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)

• Fibroblast growth factor 23 (FGF23

  Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)

Study Arms (1)

Study Arm

One armed study, blood from each patient is analysed by the following assays: Intact PTH Assay (Siemens Healthcare Diagnostics Inc); LIAISON 1-84 PTH Assay (Diasorin); PTH (1-84), biointact (Roche Diagnostics); PTH, intact (Roche Diagnostics)

Diagnostic Test: One armed study, blood from each patient is analysed by four assays ( two 3rd generation and two 2nd generation assays)

Interventions

One armed study, blood from each patient is analysed by four assays ( two 3rd generation and two 2nd generation assays) DIAGNOSTIC_TEST

Intact PTH Assay (Siemens Healthcare Diagnostics Inc); LIAISON 1-84 PTH Assay (Diasorin); PTH (1-84), biointact (Roche Diagnostics); PTH, intact (Roche Diagnostics)

Study Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

132 hemodialysis patients at a single center

You may qualify if:

• All patients who were undergoing uninterrupted hemodialysis or hemodiafiltration at the Chronic Hemodialysis Unit of the Division of Nephrology and Dialysis, Medical University of Vienna between November 1st, 2017 and December 31st, 2018.
• Existence of residual blood samples from four successive quarterly routine controls
• Age ≥ 18 years
• The test result of the assay must not have any diagnostic value or therapeutic consequence for the patients included in this study.

You may not qualify if:

• Death during the observational period (all patients must have lived through the 1-year period and must have all 4 quarterly blood draws performed on them).
• Age \<18 years

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria

Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder; Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manfred Hecking, M.D.

  Medical University of Vienna, Department of Nephrology and Dialysis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Professor Dr.

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 13, 2018
• Study Start: March 20, 2018
• Primary Completion: December 5, 2018
• Study Completion: August 7, 2019
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)