N/A
Completed N=23
Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)
Source: ClinicalTrials.gov NCT00828347 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level — 10; 4; 2; 7 participants — p=0.036
Summary
There are still no established protocols for maintenance therapy with intravenous or oral vitamin D preparations after the iPTH target has been achieved.
Therefore, the present study compared the efficacy of two maintenance therapy protocols, i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 ug/day (higher-dose group) or at a dose of 0.25 ug/day (lower-dose group), in patients with secondary hyperparathyroidism who responded to initial maxacalcitol therapy, resulting in the control of iPTH to < 150 pg/mL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level |
10; 4; 2; 7 | 0.036 sig |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of secondary hyperparathyroidism (iPTH >200 pg/mL to <500 pg/mL)
- Serum Ca < 11.0 mg/dL, and serum P < 7.0 mg/dL.
- At least one year of regular hemodialysis therapy
Exclusion Criteria
- Patients with a history of hypersensitivity to any ingredient of maxacalcitol
- Patients who had received parathyroidectomy
Data sourced from ClinicalTrials.gov (NCT00828347). 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.