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The Longitudinal PTH-Study

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ClinicalTrials.gov Identifier: NCT03464149
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ass. Prof. Dr. Manfred Hecking, MD, Medical University of Vienna

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.


Condition or disease Intervention/treatment Phase
CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder Secondary Hyperparathyroidism Kidney Replacement Diagnostic Test: One armed study, blood from each patient is analysed by four assays ( two 3rd generation and two 2nd generation assays) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Sequential Assignment
Intervention Model Description: For every patient, blood samples from four consecutive quarterly routine controls are analyzed using the four assays, respectively. This cross-sequential study design allows to study both, the agreement between two PTH assays at a given time point (i.e., cross sectionally) as well as to analyse the longitudinal variance of the analytical results of the four PTH assays (i.e., sequentially).
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intact Versus Biointact Assays for Longitudinal Assessment of Parathyroid Hormone - The Longitudinal PTH Study
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Intact PTH Assay (Siemens Healthcare Diagnostics Inc); LIAISON 1-84 PTH Assay (Diasorin); PTH (1-84), biointact (Roche Diagnostics); PTH, intact (Roche Diagnostics)




Primary Outcome Measures :
  1. Longitudinal change in PTH levels measured in [pg/ml] [ Time Frame: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12) ]
    PTH levels as measured by the second and third generation assays


Secondary Outcome Measures :
  1. Longitudinal within-patient change of PTH levels in [pg/ml] [ Time Frame: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12) ]
    Longitudinal within-patient variance of PTH over the course of 1 year, using each of two assays of the second and third generations, respectively.

  2. Serum Calcium levels [ Time Frame: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12) ]
    Serum Calcium levels

  3. Serum Phosphate levels [ Time Frame: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12) ]
    Serum Phosphate levels as measured by quarterly routine controls

  4. Fibroblast growth factor 23 (FGF23 [ Time Frame: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12) ]
    Fibroblast growth factor 23 (FGF23) as measured in quarterly routine controls



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464149


Contacts
Contact: Manfred Hecking, M.D. +43 (0)1 40400 - 55930 manfred.hecking@meduniwien.ac.at
Contact: Henrik Sliwka, M.D. +43-(0)1-40160-25175 henrik.sliwka@meduniwien.ac.at

Locations
Austria
Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria Recruiting
Vienna, Austria, 1090
Contact: Manfred Hecking, MD       manfred.hecking@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Manfred Hecking, M.D. Medical University of Vienna, Department of Nephrology and Dialysis

Responsible Party: Ass. Prof. Dr. Manfred Hecking, MD, Ass.Professor Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03464149     History of Changes
Other Study ID Numbers: The Longitudinal PTH-Study
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Rickets
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Bone Diseases
Chronic Kidney Disease-Mineral and Bone Disorder
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Musculoskeletal Diseases
Bone Diseases, Metabolic
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders