Phase 2
Completed N=47
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
Source: ClinicalTrials.gov NCT00990704 ↗Enrolled (actual)
47
Serious AEs
12.8%
Results posted
Jun 2011
Primary outcomePrimary: The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks. — 50.0; 36.4 Percentage of participants — p=0.518
Summary
This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks. |
50.0; 36.4 | 0.518 |
| SECONDARY The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks |
28.6; 15.2 | — |
| SECONDARY Mean iPTH at Each Visit |
462.7; 536.4; 507.6; 595.9; 479.2; 474.8 | — |
| SECONDARY Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks |
-208.4; -240.4 | — |
| SECONDARY Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment |
50.0; 33.3 | — |
| SECONDARY Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment |
28.6; 12.1 | — |
| SECONDARY Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline |
3.4; 4.8 | — |
| SECONDARY Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH |
2.3; 2.7 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic kidney disease (CKD) patients with iPTH >=300 pg/mL, adjusted calcium >=8.4 to = 180 mmHg and diastolic >= 110 mmHg)
- Patients with uncontrolled diabetes mellitus (defined as mean glycosylated hemoglobin >=8% for 3 months before informed consent was obtained)
- Patients with a history of drug or alcohol abuse within 6 months before informed consent was obtained
- Patients who require chronic use of cytochrome P450 (CYP3A) inhibitors or inducers
- Patients who are taking products that contain aluminum 2 weeks before informed consent was obtained
- Patients who have taken paricalcitol in the past
Data sourced from ClinicalTrials.gov (NCT00990704). 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.