Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
132 hemodialysis patients at a single center
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Manfred Hecking, M.D. | Medical University of Vienna, Department of Nephrology and Dialysis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria | Vienna | 1090 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum
|
| Serum Calcium levels |
Serum Calcium levels |
| 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 | 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 | Timepoints of four consecutive quarterly routine controls per patient (month 1; month 4 ; month 8, month 12) |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |