Phase 3
Completed N=255
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Source: ClinicalTrials.gov NCT01341782 ↗Enrolled (actual)
255
Serious AEs
9.8%
Results posted
Jun 2013
Primary outcomePrimary: Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia — 27.7; 30.5 percentage of participants
Summary
This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia |
27.7; 30.5 | — |
| SECONDARY Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia |
34.6; 39.1 | — |
| SECONDARY Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) |
31.5; 32.8 | — |
| SECONDARY Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline |
44.9; 50.8 | — |
| SECONDARY Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline |
3.9; 5.3 | — |
| SECONDARY Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL |
2.6; 3.4 | — |
Eligibility Criteria
Inclusion Criteria
- Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders
- On three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus (P) less than or equal to 6.5 mg/dL.
Exclusion Criteria
- Patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes
- Patients who have received a parathyroidectomy or ethanol infusion within the prior year
- Patients taking drugs that affect iPTH, calcium or bone metabolism
- Patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
- Female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.
Data sourced from ClinicalTrials.gov (NCT01341782). 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.