[Translation] An open-label, multicenter, single-cohort, post-marketing phase IV study to evaluate the efficacy, pharmacodynamics, and safety of the anti-FGF23 antibody KRN23 in Chinese adult patients with tumor-induced osteomalacia (TIO)

评估KRN23治疗对中国成年TIO患者血磷水平的药效学（PD）影响

[Translation]

To evaluate the pharmacodynamic (PD) effect of KRN23 treatment on serum phosphorus levels in Chinese adult patients with TIO

Start Date11 Aug 2022

Sponsor / Collaborator

Kyowa Kirin Co., Ltd.

[+1]

CTR20192259 / CompletedPhase 1

KHK7580在健康成人志愿者中的药代动力学研究

[Translation] Pharmacokinetic study of KHK7580 in healthy adult volunteers

主要目的是评价在中国健康成年志愿者中单次和多次口服KHK7580后KHK7580的药代动力学特征。次要目的是评价其安全性和药效学。

[Translation]

The primary objective was to evaluate the pharmacokinetic characteristics of KHK7580 after single and multiple oral administrations in healthy adult Chinese volunteers. The secondary objectives were to evaluate its safety and pharmacodynamics.

Start Date20 Dec 2019

Sponsor / Collaborator

Kyowa Kirin Co., Ltd.

[+2]

CTR20200303 / CompletedPhase 3

KHK7580和盐酸西那卡塞在继发性甲状旁腺功能亢进症患者中的Ⅲ期随机双盲、受试者自身剂量调整、平行组研究

[Translation] A phase III randomized, double-blind, subject-adjusted, parallel-group study of KHK7580 and cinacalcet hydrochloride in patients with secondary hyperparathyroidism

本研究的目的是在以采用盐酸西那卡塞作为阳性对照药的随机化、双盲、受试者自身剂量调整、平行组设计中，评价接受血液透析治疗的继发性甲状旁腺功能亢进症（SHPT）患者连续52周每天一次口服KHK7580的有效性和安全性。

[Translation]

The aim of this study was to evaluate the efficacy and safety of once-daily oral KHK7580 for 52 weeks in patients with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, subject-adjusted, parallel-group design with cinacalcet hydrochloride as an active control.

Start Date13 Aug 2019

Sponsor / Collaborator

Kyowa Kirin Co., Ltd.

[+2]

100 Clinical Results associated with Kyowa Hakko Kirin China Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Kyowa Hakko Kirin China Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Kyowa Hakko Kirin China Pharmaceutical Co., Ltd.

01 Jun 2020·Nephrology Dialysis Transplantation

P0890EFFICACY AND SAFETY OF CINACALCET IN CHINESE MAINTENANCE HEMODIALYSIS PATIENTS WITH DIFFERENT STAGES OF SECONDARY HYPERPARATHYROIDISM: INTERIM ANALYSIS RESULTS OF ACTIVE STUDY

Author: Ding, Guohua ; He, Qiang ; Jin, Hui ; Liu, Hong ; Zhang, Yunyan ; Hao, Li ; Ni, Zhaohui ; Chen, Xiao-Nong ; Mao, Yonghui ; Wang, Shixiang ; Fu, Ping ; Yang, Junwei ; Liu, Zhang-suo ; Chen, Chaosheng ; Zuo, Li ; Ye, Jian-ming ; Niu, Jianying ; Lou, Jizhuang ; Zhi-hong, Liu ; Xiao, Guanqing ; Ling, Yisheng ; Jiang, Aili ; Li, Xuemei ; Chen, Jing ; Zhang, Aihua

AbstractBackground and AimsChronic kidney disease (CKD) is a major public health issue worldwide including in China. One of the most common complication in advanced Chronic kidney disease (CKD) is secondary hyperparathyroidism (SHPT). Reports show higher risk of bone fracture, cardiovascular events and all-cause mortality is associated with uncontrolled SHPT in patients with CKD. Cinacalcet, a calcimimetic agent was reported to reduce iPTH levels without Ca increase in patients with SHPT previously. However there has been no large-cohort study and stratified analysis of cinacalcet based on the level of iPTH in China. Moreover, the optimal therapeutic doses of cinacalcet with mild-to-severe SHPT is remaining unknown. ACTIVE study is an IV, open-label, multicenter clinical trial aimed to: (1) evaluate the efficacy and safety of cinacalcet in maintenance hemodialysis patients with mild-to-severe SHPT; (2) explore optimal combinations therapy with cinacalcet and other agents for treating patients with CKD-mineral and bone disorder. (3) investigate the benefit of long-term, continuous medication with cinacalcet in the real-world setting.MethodThe study design was reported on 2019 ASN. Key inclusion criteria were a baseline iPTH ≥300 pg/mL with life expectancy of ≥2 years, and ≥12 weeks of maintenance dialysis (three dialysis sessions per week) prior to enrollment. The enrollments were grouped based on their iPTH level as having mild (300-600 pg/mL), moderate (600-900 pg/mL) or severe (≥900 pg/mL). Patients initiated treatment with cinacalcet orally at a starting dose of 25 mg once daily (qd). The primary efficacy endpoint is the proportion of patients achieving iPTH targets (iPTH between 150-300pg/mL) at 20 and 32 weeks after the initiation of cinacalcet treatment. Adverse events and serious adverse events were recorded. An interim analysis was scheduled as 375 patients completed 32 weeks visit.Results911 patients were recruited and of 750 eligible patients, 275 were identified as mild, 224 were considered as moderate and left 251 were grouped as severe SHPT. The study flowchart of 375 patients including mild(127), moderate(106) and severe(142) SHPT for interim analysis was shown in Fig 1. The baseline results including demographic and biomarkers level were reported on 2019 ASN. After 4 weeks’ cinacalcet treatment, serum PTH decreased in all three group, while extremely remarkable in the severe SHPT group. Interim analysis results revealed that the proportion of patients achieving iPTH target (150-300 pg/mL) at 20 wk visit among mild, moderate and severe groups were 38.61% (39/101), 30.11% (28/93) and 10.91% (12/110) respectively. The proportion of patients achieving iPTH target at 32 wk visit in 3 groups increased to 44.68% (42/94), 27.27% (24/88) and 14.56% (15/103) respectively (Table.1). The trends of the proportion of patients achieving iPTH target increased in all 3 different groups (Fig.2). The safety analysis showed the most common treatment-related AE in top 3 including hypocalcemia, hyperlipidemia, and loss of appetite. In vital signs, electrocardiogram (ECG) and laboratory examination of descriptive analysis, found no obvious safety tips. This study is sponsored by Kyowa Hakko Kirin (China) Pharmaceutical Co., Ltd. The analysis is still ongoing and results will be released at EDTA meeting this year.ConclusionOral cinacalcet HCl was effective and safe in reducing iPTH in patients receiving HD with mild-to-severe SHPT.

01 Feb 2016·Clinical TherapeuticsQ4 · MEDICINE

Pharmacokinetic and Pharmacodynamic Properties of Cinacalcet (KRN1493) in Chinese Healthy Volunteers: A Randomized, Open-label, Single Ascending–dose and Multiple-dose, Parallel-group Study

Q4 · MEDICINE

Article

Author: Wang, Hongyun ; Gao, Feng ; Chen, Xia ; Hu, Pei ; Jiang, Ji ; Liu, Tao ; Liu, Hongzhong

PURPOSEThe aim of this study was to assess the pharmacokinetic (PK) and pharmacodynamic (PD) properties and safety of single and multiple doses of cinacalcet in Chinese healthy volunteers (HVs) for the purposes of a New Drug Application package for the Chinese Food and Drug Administration.METHODSIn this randomized, open-label, single ascending-dose and multiple-dose, parallel-group study, 42 Chinese HVs were randomized to receive a single oral dose of 25, 50, or 100 mg of cinacalcet and multiple doses of 50 mg of cinacalcet once daily for 7 days. Plasma cinacalcet concentrations were analyzed by HPLC-MS/MS. The PK parameters were assessed with noncompartmental analysis. Plasma intact parathyroid hormone, serum calcium, and phosphorus concentrations were measured for PD evaluation. The safety profile was also assessed. Adverse events (AEs) were noted during the study.FINDINGSOf the 42 randomized HVs, 41 completed the study per protocol; 1 prematurely discontinued the study because of AEs. Cinacalcet has nonlinear PK properties over a dose range of 25 to 100 mg after a single dose. Mean (SD) Cmax values were 7.68 (4.25), 17 (6.33), and 31.3 (16.42) ng/mL with single doses of 25, 50, and 100 mg of cinacalcet, respectively. Mean (SD) AUC0- last values were 58.4 (25.38), 187 (70.7), and 367 (180.03) hr∙ng/mL with single doses of 25, 50, and 100 mg of cinacalcet, respectively. Steady state was attained within 7 doses of successive daily administration of 50 mg of cinacalcet. At steady state, the mean (SD) Cmax and AUC0-last values were 20.6 (9.63) ng/mL and 297 (146.15) ng∙h/mL. The accumulation ratios of Cmax and AUC (AUCτ/AUC0-24) were 1.21 and 1.32. Plasma intact parathyroid hormone and serum calcium concentrations had similar patterns, both decreased after administration of cinacalcet, whether after single dose or multiple doses. A total of 52 AEs were reported in 20 HVs (47.6%). The most frequently reported AEs after single-dose and multiple-dose cinacalcet administration were hypocalcemia, numbness, dizziness, and muscle soreness. No serious AEs were reported.IMPLICATIONSCinacalcet was well tolerated and effective after administration of a single oral dose up to 100 mg and multiple doses of 50 mg of cinacalcet once daily for 7 days. Cinacalcet has nonlinear PK properties over a dose range of 25 to 100 mg after a single dose. PK profiles after multiple doses were similar to those after a single dose with no accumulation. Cinacalcet had similar PK and safety profiles between Chinese and Western HVs at the same dose levels.

100 Deals associated with Kyowa Hakko Kirin China Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Kyowa Hakko Kirin China Pharmaceutical Co., Ltd.

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