N/A
N=994
Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
Chronic Kidney Disease · Secondary Hyperparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT01224782 ↗Enrolled (actual)
994
Serious AEs
2.7%
Results posted
Sep 2014
Primary outcome: Primary: Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values — 3.82 months
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
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values |
3.82 | — |
| PRIMARY Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 |
7.4 | — |
| SECONDARY Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) |
75.3 | — |
| SECONDARY Percentage of Participants With Hypercalcemia |
0.9 | — |
| SECONDARY Mean Weekly Dose of Zemplar (Paricalcitol) |
6.29; 5.77 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
141; 27; 14; 14; 14; 13 | — |
Summary
The aims of this post-marketing observational study (PMOS) are to evaluate the time period needed to achieve > 30% decrease of intact parathyroid hormone (iPTH) compared to the initial values and to provide data on the tolerability and compliance of treatment with Zemplar (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical practice.
Eligibility Criteria
Inclusion Criteria
- Patients 18 years of age or older
- Patients with chronic kidney disease (CKD) stage 3 and 4 and secondary hyperparathyroidism (SHPT)
- Patients with Intact Parathyroid Hormone (iPTH) > 70 pg/mL and with chronic kidney disease (CKD) stage 3 or with Intact Parathyroid Hormone (iPTH) > 110 pg/mL and with chronic kidney disease (CKD) stage 4
- Patients clinically indicated for treatment with Zemplar capsules
- Patient must provide the authorization to use his/her data for statistical evaluation before entering to the post marketing observational study (PMOS). Local Law requirements are to be followed
Exclusion Criteria
- Patients with clinically important hypercalcemia = Calcium > 2.6 mmol/L (10.5 mg/dL)
- Patients suffering from proved intoxication of vitamin D or patient with known hypersensitivity to paricalcitol or any other part of the product
Data sourced from ClinicalTrials.gov (NCT01224782). 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.