N/A
Completed N=759
Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice
Kidney Insufficiency · Hyperparathyroidism
Source: ClinicalTrials.gov NCT01083849 ↗
Enrolled (actual)
759
Serious AEs
27.6%
Results posted
Dec 2014
Primary outcomePrimary: Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months — 30.4; 30.5; 70.2 percentage of participants
Summary
The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months |
30.4; 30.5; 70.2 | — |
| PRIMARY Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months |
212.4; 195.5; 145.7 | — |
| SECONDARY Number of Participants With Hypercalcemia |
1; 2; 2; 6; 1; 4 | — |
| SECONDARY Number of Participants With Hyperphosphatemia |
5; 192; 8; 153; 8; 151 | — |
| SECONDARY Number of Participants With Elevated Calcium-Phosphorus Product |
5; 102; 6; 97; 7; 101 | — |
| SECONDARY Mean Duration of Hospitalization by Visit |
1.3; 0.7; 1.8; 0.8; 2.9; 0.8 | — |
| SECONDARY Mean Duration of Disability by Visit |
0.0; 0.3; 4.7; 0.2; 0.0; 0.4 | — |
| SECONDARY Mean Intact Parathormone (iPTH) Levels by Visit |
29.65; 54.85; 26.95; 37.20; 23.01; 37.18 | — |
| SECONDARY Mean Calcium-Phosphate Product Levels by Visit |
3.32; 4.12; 3.50; 4.30; 3.62; 4.32 | — |
Eligibility Criteria
Inclusion Criteria
- The inclusion criteria are based on the Summary of Product Characteristics for paricalcitol injection and capsules: Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease
- Patients not treated with paricalcitol for at least 6 months prior to inclusion in this study
Exclusion Criteria
- The contraindications listed in the Summary of Product Characteristics for paricalcitol injection and capsules apply
- An additional exclusion criterion is a parathyroid hormone- value of > 1000 pg/mL (which may be a sign of tertiary hyperparathyroidism) and existing treatment with paricalcitol
Data sourced from ClinicalTrials.gov (NCT01083849). 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.