N/A
N=67
Study to Evaluate the Effect of Intravenous (IV) Paricalcitol (Zemplar) on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years
Secondary Hyperparathyroidism · Chronic Kidney Disease Stage V · Cardiac Morbidity
Bottom Line
View on ClinicalTrials.gov: NCT01073462 ↗Enrolled (actual)
67
Serious AEs
46.3%
Results posted
Jul 2014
Primary outcome: Primary: Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range — 28.4; 43.3; 35.8; 38.8 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range |
28.4; 43.3; 35.8; 38.8; 37.3; 35.8 | — |
| SECONDARY Percentage of Participants With Hypercalcemia |
0.0; 0.0; 0.0; 1.5; 0.0; 1.5 | — |
| SECONDARY Percentage of Participants With Hyperphosphatemia |
0.0; 28.4; 31.3; 25.4; 23.9; 22.4 | — |
| SECONDARY Percentage of Participants With at Least a 30%-Reduction in iPTH Levels |
41.8; 40.3; 47.8; 52.2; 47.8 | — |
| SECONDARY Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements |
44.8 | — |
| SECONDARY Percentage of Participants With at Least One Concomitant Medication |
80.6; 68.7; 43.3; 13.4; 86.6 | — |
| SECONDARY Percentage of Participants Experiencing Hospitalization |
41.8; 14.9; 37.3 | — |
| SECONDARY Number of Participants With Cardiac Disease Progression |
2; 2; 4; 0; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01073462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.