Secondary Hyperparathyroidism Clinical Trial
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02549417 -
Phase 3 Study of KHK7580
|
Phase 3 | |
| Completed |
NCT02549404 -
Phase 3 Study of KHK7580
|
Phase 3 | |
| Completed |
NCT02549391 -
Phase 3 Study of KHK7580
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT02536287 -
Comparison of Total Parathyroidectomy With and Without Autotransplantation
|
Phase 3 | |
| Active, not recruiting |
NCT03023748 -
Intravenous Paricalcitol in Chronic Hemodialysis Patients
|
Phase 4 | |
| Withdrawn |
NCT01426724 -
Effects of Vitamin D on Renal Blood Flow, Proteinuria and Inflammation in Patients With Chronic Kidney Disease
|
N/A | |
| Completed |
NCT01101113 -
Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level
|
Phase 4 | |
| Completed |
NCT01220050 -
Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism
|
Phase 2 | |
| Completed |
NCT00537979 -
Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
|
Phase 4 | |
| Completed |
NCT00379899 -
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
|
Phase 4 | |
| Completed |
NCT00431496 -
A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)
|
Phase 4 | |
| Completed |
NCT00073710 -
Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
|
Phase 4 | |
| Completed |
NCT00117052 -
SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
|
Phase 3 | |
| Completed |
NCT03626948 -
SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
|
Phase 3 | |
| Completed |
NCT01382212 -
A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
|
Phase 3 | |
| Completed |
NCT01219855 -
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
|
Phase 2/Phase 3 | |
| Completed |
NCT01224782 -
Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
|
N/A | |
| Completed |
NCT00990704 -
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
|
Phase 2 | |
| Completed |
NCT00999037 -
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
|
N/A | |
| Completed |
NCT00742716 -
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
|
Phase 2 |