CKD-MBD - Chronic Kidney Disease Mineral and Bone DisorderNCT03464149
The Longitudinal PTH-Study
An observational study of CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder and Secondary Hyperparathyroidism, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder, Secondary Hyperparathyroidism, Kidney Replacement
- What is being tested?
- One armed study, blood from each patient is analysed by four assays ( two 3rd generation and two 2nd generation assays)
- How many people
- 132 participants
- Where
- 1 siteAustria
- Study dates
- 20 Mar 2018to 7 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 132 hemodialysis patients at a single center
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria
Vienna, 1090
About this study
Official title: Intact Versus Biointact Assays for Longitudinal Assessment of Parathyroid Hormone - The Longitudinal PTH Study
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
- Being tested
- One armed study, blood from each patient is analysed by four assays ( two 3rd generation and two 2nd generation assays)
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder, Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: One armed study, blood from each patient is analysed by four assays ( two 3rd generation and two 2nd generation assays) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal change in PTH levels measured in [pg/ml]
PTH levels as measured by the second and third generation assays
Measured: 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]
Longitudinal within-patient variance of PTH over the course of 1 year, using each of two assays of the second and third generations, respectively.
Measured: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)
Serum Calcium levels
Serum Calcium levels
Measured: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)
Serum Phosphate levels
Serum Phosphate levels as measured by quarterly routine controls
Measured: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)
Fibroblast growth factor 23 (FGF23
Fibroblast growth factor 23 (FGF23) as measured in quarterly routine controls
Measured: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start20 Mar 2018
- Primary completion5 Dec 2018
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD-MBD - Chronic Kidney Disease Mineral and Bone DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Dr. Manfred Hecking, MD PhD, Medical University of Vienna
- Investigators
- Manfred Hecking, M.D., Principal investigator, Medical University of Vienna, Department of Nephrology and Dialysis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464149
- Sponsor's protocol ID
- The Longitudinal PTH-Study
- Status last verified
- Jun 2020
- First submitted
- 12 Feb 2018
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intact Versus Biointact Assays for Longitudinal Assessment of Parathyroid Hormone - The Longitudinal PTH Study
- ClinicalTrials.gov ID
- NCT03464149
- Acronym / sponsor ID
- The Longitudinal PTH-Study
- Conditions
- CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder, Secondary Hyperparathyroidism, Kidney Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | – | Diagnostic Test: One armed study, blood from each patient is analysed by four assays ( two 3rd generation and two 2nd generation assays)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 132 hemodialysis patients at a single center
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Diagnostic test | Study Arm |
Primary outcome
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
4 secondary outcomes
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)
Serum Calcium levels
Time frame: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)
Serum Phosphate levels
Time frame: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)
Fibroblast growth factor 23 (FGF23
Time frame: Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Hecking, M.D. principal investigator
Medical University of Vienna, Department of Nephrology and Dialysis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder and Secondary Hyperparathyroidism, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.