Secondary Hyperparathyroidism Clinical Trial
Official title:
Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience
The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.
This was a single arm, open, multicenter, non-interventional, post marketing observational
study, which has been conducted in 24 sites in Greece, under normal clinical practice and as
per the locally approved Summary of Product Characteristics (SmPC) of study medication (oral
paricalcitol). Eligible patients were followed up for a 12-month period after enrollment.
All study activities were consistent with European Union (EU) directive 2001/20/EC section
for non-interventional studies.
In this study, paricalcitol was prescribed on an on-label basis in an everyday setting to
observe drug actions in a distinct geography (Greece with > 250 days/year of sunny days) as
well as in a significant subpopulation (Chronic Kidney Disease [CKD] stages 3-5 transplanted
patients). Dose tolerability, treatment effects, as well as maintenance of results were
registered for a 12-month period in order to obtain experience in the long term use of
paricalcitol capsules. Furthermore, in centers where additional blood parameters were
examined as part of clinical routine, these were recorded and analyzed.
;
Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02549417 -
Phase 3 Study of KHK7580
|
Phase 3 | |
| Completed |
NCT02549404 -
Phase 3 Study of KHK7580
|
Phase 3 | |
| Not yet recruiting |
NCT02536287 -
Comparison of Total Parathyroidectomy With and Without Autotransplantation
|
Phase 3 | |
| Completed |
NCT02549391 -
Phase 3 Study of KHK7580
|
Phase 2/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| Withdrawn |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 |
NCT00999037 -
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
|
N/A | |
| Completed |
NCT00990704 -
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
|
Phase 2 | |
| Completed |
NCT00742716 -
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
|
Phase 2 |