Abstract | AIM: MATERIALS AND METHODS: Subjects with SHPT (n = 216) undergoing hemodialysis were treated with paricalcitol i.v. for 12 weeks. One group was treated according to the EU paricalcitol package insert (PI) (initial μg dose based on iPTH/80), and the other was treated according to the US PI (initial dose of 0.04 μg/kg). Dose titration was based on iPTH and serum calcium (Ca) and phosphorus (P) levels. RESULTS: The primary endpoint of two consecutive ≥ 30% iPTH decreases was achieved by 88.6% and 55.9% of subjects in the EU and US PI groups, respectively. Noninferiority of the EU PI group vs. the US PI group was demonstrated (lower bound of the 1-sided 97.5% CI = 21.3%). Superiority of the EU PI group was shown (lower limit > 0%) and confirmed by Fisher's exact test (p < 0.001); both groups showed similar achievement of recommended KDIGO iPTH levels. Ca and P levels were relatively constant. CONCLUSION: Both EU and US PI paricalcitol dosing strategies effectively reduced iPTH levels in Chinese subjects with SHPT, with minimal impact on Ca and P levels.
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Authors | Yucheng Yan, Jiaqi Qian, Nan Chen, Zhaoxing Huang, Gengru Jiang, Xuewang Li, Hongli Lin, Liqiu Liu, Mei Wang, Changying Xing, Xueqing Yu, Li Zuo, Michael Amdahl, Samina Khan |
Journal | Clinical nephrology
(Clin Nephrol)
Vol. 81
Issue 1
Pg. 20-9
(Jan 2014)
ISSN: 0301-0430 [Print] Germany |
PMID | 24131674
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Ergocalciferols
- Parathyroid Hormone
- Phosphorus
- paricalcitol
- Calcium
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Topics |
- Adult
- Aged
- Calcium
(blood)
- Ergocalciferols
(administration & dosage, adverse effects, therapeutic use)
- Female
- Humans
- Hyperparathyroidism, Secondary
(blood, drug therapy)
- Male
- Middle Aged
- Parathyroid Hormone
(blood)
- Phosphorus
(blood)
- Single-Blind Method
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