N/A
Completed N=237
Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
Chronic Kidney Failure · Hyperparathyroidism
Source: ClinicalTrials.gov NCT01081665 ↗
Enrolled (actual)
237
Serious AEs
39.7%
Results posted
Mar 2012
Primary outcomePrimary: Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations — 152; 85; 59; 16 participants
Summary
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations |
152; 85; 59; 16; 10 | — |
| PRIMARY Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized |
16.1 | — |
| SECONDARY The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml) |
78.3 | — |
| SECONDARY The Incidence of Clinically Significant Hypercalcemia |
16 | — |
| SECONDARY The Incidence of Clinically Significant Hyperphosphatemia |
107 | — |
| SECONDARY The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product |
81 | — |
| SECONDARY To Estimate the Incidence of (S)AEs/(S)ADRs |
196; 170; 94; 127; 10; 43 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is >= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone > 300 pg/mL.
- Subject is receiving chronic hemodialysis.
- Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
- Subject has provided their informed consent to participate.
Exclusion Criteria
- Subject has a corrected serum calcium > 10.5 mg/dL, serum phosphorus >= 6.5 mg/dL or subjects with corrected Ca x P >= 65 mg^2/dl^2.
- Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
- Subject has participated in clinical study within the last month.
- Zemplar is contraindicated according to the Summary of Product Characteristics.
Data sourced from ClinicalTrials.gov (NCT01081665). 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. Informational only — not medical advice.