Paricalcitol Capsule (HR081702) for Secondary Hyperparathyroidism (SHPT) in Stages 3 and 4 CKD: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study
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Le résumé fourni par la source
Background: Paricalcitol capsule is a good choice to treat SHPT as a vitamin D analogue with a convenient dosage form for patients. This study aimed to investigate the efficacy and safety of paricalcitol capsule (HR081702) in stages 3/4 CKD patients with SHPT. Methods: This was a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in Chinese adult patients in stages 3/4 CKD with SHPT (ClinicalTrials.gov, NCT04994080). Patients were enrolled if, in the screening period and run-in period, the mean serum intact parathyroid hormone (iPTH) was ≥150 pg/mL (≥120 pg/mL in both periods), serum calcium level was between 8.0 and 10.0 mg/dL (1.99 and 2.50 mmol/L), and serum phosphorus level was ≤5.2 mg/dL (1.68 mmol/L). Eligible patients were randomized (2:1) to receive HR081702 or placebo orally once a day for 24 weeks, with the initial dose determined by iPTH level and adjusted depending on subsequent serum iPTH, calcium, and phosphorus levels. The primary endpoint was the proportion of patients with at least two consecutive iPTH reductions of ≥30% from baseline within 24 weeks of treatment. Results: A total of 90 patients were randomized (60 in HR081702 group and 30 in placebo group) with similar baseline characteristics between the two groups. During the 24 weeks treatment period, 91.7% of patients in the HR081702 group achieved two consecutive reductions of ≥30% from baseline in iPTH levels, compared with 16.7% of patients in the placebo group (difference, 75.0% [95% CI 59.9-90.1]; P<0.0001). Furthermore, 68.3% of HR081702-treated patients achieved four consecutive decreases of ≥30% in iPTH levels from baseline, compared with 6.7% of placebo-treated patients. There were no obvious differences in the excretion of calcium and phosphorus or in the decline of kidney function between the two groups. Treatment-related adverse events were reported by 50% in HR081702 group and 26.7% in placebo group (all were mild or moderate). The most common ones were hyperphosphatemia and urinary tract infection. Conclusion: Paricalcitol capsule (HR081702) was an effective and safe treatment for stages 3/4 CKD patients with SHPT. Funding: Commercial Support - Jiangsu Hengrui Pharmaceuticals Co., Ltd
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Paricalcitol Capsule (HR081702) for Secondary Hyperparathyroidism (SHPT) in Stages 3 and 4 CKD: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study
- Date Crossref
- 01/10/2024
- Éditeur
- Ovid Technologies (Wolters Kluwer Health)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Shanghai Clinical Research Center pays non établi dans la noticeStructure de recherche
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Zhejiang University pays non établi dans la noticeUniversité ou école supérieure
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Northern Jiangsu People's Hospital pays non établi dans la noticeÉtablissement de santé
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Second Affiliated Hospital of Jilin University pays non établi dans la noticeÉtablissement de santé
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Tianjin First Center Hospital pays non établi dans la noticeÉtablissement de santé
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Tianjin Medical University pays non établi dans la noticeUniversité ou école supérieure
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General Hospital of Shenyang Military Region pays non établi dans la noticeÉtablissement de santé
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Dalian Medical University pays non établi dans la noticeUniversité ou école supérieure
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First Affiliated Hospital of Dalian Medical University pays non établi dans la noticeÉtablissement de santé
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Shanxi Medical University pays non établi dans la noticeUniversité ou école supérieure
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Second Hospital of Shanxi Medical University pays non établi dans la noticeÉtablissement de santé
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China Medical University pays non établi dans la noticeUniversité ou école supérieure
Shanghai Clinical Research Center, Zhejiang University et Northern Jiangsu People's Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.