N/A
Completed N=60
Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands
Kidney Failure, Chronic
Source: ClinicalTrials.gov NCT01273597 ↗
Enrolled (actual)
60
Serious AEs
15.0%
Results posted
Dec 2012
Primary outcomePrimary: Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection) — 12.2 weeks
Summary
This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will be collected from participants initiated on Zemplar therapy according to standard of care. The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the proportion of participants achieving target parathyroid hormone levels, and prevalence of elevated serum calcium and phosphate levels will be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection) |
12.2 | — |
| SECONDARY Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6 |
14 | — |
| SECONDARY Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance |
— | — |
| SECONDARY Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance |
— | — |
| SECONDARY Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism |
— | — |
| SECONDARY Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy |
5 | — |
| SECONDARY Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment |
20 | — |
| SECONDARY Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy |
39 | — |
| SECONDARY Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment |
50 | — |
Eligibility Criteria
Inclusion Criteria
Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:
- ≥ 18 years of age,
- Willing to sign the patient information and informed consent form,
- Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:
- between 500-800 pg/mL with at least two abruption of conventional vitamin D therapy due to elevated serum calcium level (i.e. > 2.4 mmol/L) in the medical history, or
- higher than 800 pg/mL and parathyroidectomy is contraindicated.
- The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.
Exclusion Criteria
Patients cannot be enrolled in the study if any of the following exclusion criteria apply:
- The patient is already treated with Zemplar (paricalcitol injection),
- Any contraindication exists as stated in the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection),
- Patients who decline to participate in the study or decline to sign the patient information/informed consent form.
Data sourced from ClinicalTrials.gov (NCT01273597). 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.