Secondary Hyperparathyroidism Clinical Trial
Official title:
Postmarketing Observational Study to Evaluate the Effect of Zemplar (Paricalcitol IV) on Cardiac Morbidity in Patients With Chronic Kidney Disease Stage 5 Over 2 Years.
Verified date | June 2014 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Federal Office for Safety in Health Care |
Study type | Observational |
The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines (150 - 300 pg/mL) after 2 years.
Status | Completed |
Enrollment | 67 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients aged at least 18 years - Patients with secondary hyperparathyroidism associated with CKD stage 5, serum iPTH > 150 pg/mL, - Cardiac disease as described by Medical Dictionary for Regulatory Activities (MedDRA) terms: - cardiac disorder as cardiac arrhythmias - cardiac disorder signs and symptoms - cardiac neoplasm - cardiac valve disorder - heart failures - myocardial disorder - pericardial disorder - Serum phosphate level < 6.5 mg/dL and serum calcium level < 10.5 mg/dL Exclusion Criteria: - Patients who meet contraindications as outlined in the latest version of Zemplar (Paricalcitol IV) summary of product characteristics - Patients with known hypersensitivity to paricalcitol or any component of the formulation, vitamin D intoxication, hypercalcemia; cinacalcet as concomitant medication. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Austria | Site Reference ID/Investigator# 27447 | Graz | |
Austria | Site Reference ID/Investigator# 27483 | Graz | |
Austria | Site Reference ID/Investigator# 49182 | Graz | |
Austria | Site Reference ID/Investigator# 52742 | Graz | |
Austria | Site Reference ID/Investigator# 27487 | Innsbruck | |
Austria | Site Reference ID/Investigator# 27484 | Linz | |
Austria | Site Reference ID/Investigator# 36983 | Linz | |
Austria | Site Reference ID/Investigator# 27485 | Rottenmann | |
Austria | Site Reference ID/Investigator# 10981 | Vienna | |
Austria | Site Reference ID/Investigator# 27446 | Vienna | |
Austria | Site Reference ID/Investigator# 27482 | Vienna | |
Austria | Site Reference ID/Investigator# 53469 | Vienna |
Lead Sponsor | Collaborator |
---|---|
AbbVie (prior sponsor, Abbott) | Assign Data Management and Biostatistics GmbH |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range | Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL). | Baseline and Months 3, 6, 12, 18, and 24 | No |
Secondary | Percentage of Participants With Hypercalcemia | Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement. Serum calcium was measured at every study visit. | Baseline and Months 3, 6, 12, 18, and 24 | No |
Secondary | Percentage of Participants With Hyperphosphatemia | Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement. Serum phosphate was measured at every study visit. | Baseline and Months 3, 6, 12, 18, and 24 | No |
Secondary | Percentage of Participants With at Least a 30%-Reduction in iPTH Levels | The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level. | Baseline and Months 3, 6, 12, 18, and 24 | No |
Secondary | Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements | The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits. | Baseline to Month 24 | No |
Secondary | Percentage of Participants With at Least One Concomitant Medication | The percentage of participants with at least one concomitant medication during the course of the study, by the following types: Phosphate binder Epoetin Renin-Angiotensin-Aldosterone System (RAAS) inhibitors Cinacalcet Other |
24 months | No |
Secondary | Percentage of Participants Experiencing Hospitalization | The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study. | 24 months | No |
Secondary | Number of Participants With Cardiac Disease Progression | Cardiac disease progression was determined by the Investigator. | Month 3, 6, 12, 18, and 24 | No |
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 |
NCT00117052 -
SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
|
Phase 3 | |
Completed |
NCT00073710 -
Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
|
Phase 4 | |
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 |
NCT01224782 -
Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
|
N/A | |
Completed |
NCT01219855 -
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
|
Phase 2/Phase 3 | |
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 |