Intact Versus Biointact Assays for Longitudinal Assessment of Parathyroid Hormone - The Longitudinal PTH Study

The Longitudinal PTH-Study



Sponsors


Source

Medical University of Vienna

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2018-03-20

Completion Date

2019-04-01

Primary Completion Date

2019-04-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Longitudinal change in PTH levels measured in [pg/ml]
Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)

Secondary Outcome

Measure

Time Frame

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)

Enrollment

100

Conditions


Intervention

Intervention Type

Diagnostic Test

Intervention Name


Description

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

Arm Group Label

Study Arm


Eligibility

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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Manfred Hecking, M.D.
Principal Investigator
Medical University of Vienna, Department of Nephrology and Dialysis

Overall Contact

Last Name

Manfred Hecking, M.D.

Phone

+43 (0)1 40400 - 55930

Email

manfred.hecking@meduniwien.ac.at


Location

Facility

Status

Contact

Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria
Vienna 1090 Austria
Recruiting
Last Name: Manfred Hecking, MD
Email: manfred.hecking@meduniwien.ac.at

Location Countries

Country

Austria


Verification Date

2018-05-01

Lastchanged Date

2018-03-12

Firstreceived Date

2018-02-12

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Medical University of Vienna

Investigator Full Name

Ass. Prof. Dr. Manfred Hecking, MD

Investigator Title

Ass.Professor Dr.


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Arm Group

Arm Group Label

Study Arm

Arm Group Type

Experimental

Description

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)


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Henrik Sliwka, M.D.

Phone

+43-(0)1-40160-25175

Email

henrik.sliwka@meduniwien.ac.at


Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

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).

Primary Purpose

Diagnostic

Masking

None (Open Label)


Study First Submitted

February 12, 2018

Study First Submitted Qc

March 12, 2018

Study First Posted

March 13, 2018

Last Update Submitted

May 22, 2018

Last Update Submitted Qc

May 22, 2018

Last Update Posted

May 23, 2018


ClinicalTrials.gov processed this data on May 23, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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