Abstract: FR-PO131
Efficacy and Safety of Cinacalcet in Chinese Maintenance Hemodialysis Patients with Different Stages of Secondary Hyperparathyroidism: Rationale and Design of ACTIVE Study
Session Information
- Bone and Mineral Metabolism: Phosphorus, FGF23, Vascular Calcification
November 08, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 402 Bone and Mineral Metabolism: Clinical
Author
- Liu, Zhihong, National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, JIangSu, China
Group or Team Name
- ACTIVE study group
Background
Secondary hyperparathyroidism (SHPT), as a common complication in advanced Chronic kidney disease (CKD) has become a global public health problem. Patients with CKD and uncontrolled SHPT are at high risk of cardiovascular events and associated mortality. Cinacalcet, a calcimimetic agent was reported to effectively and safely reduce PTH levels in CKD patients with SHPT previously. However there has been no large-scale study and stratified analysis of cinacalcet in China and the optimal therapeutic doses of different levels of severity of SHPT still remain unknown.
Methods
A phase IV, open-label, multicenter study was designed and conducted in 23 hospitals in China. The study was performed in two phases. In phase 1, a cohort study for 32 weeks follow-up was designed to explore the efficacy and safety of cinacalcet. In phase 2, a real-world study of 20 additional weeks was designed in which patients completing the cohort study decided on their own whether to continue taking cinacalcet at their own cost or not. Patients with a baseline iPTH ≥300 pg/mL should receive at least 12 weeks of maintenance hemodialysis before enrollment. 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 (shown in Fig.1)
Results
Up to 2019/05/12, a total of 750 maintenance hemodialysis patients with SHPT were enrolled and stratified into 3 groups according to baseline iPTH level （mild 300~600, moderate 600~900 and severe ≥900 pg/mL respectively). The trial is still in progress and enrollment has been completed. Analysis of the baseline data is ongoing and the corresponding results will be released at ASN meeting this year.
Conclusion
We expect that the results of this study will allow us to draw valuable conclusions related to these objectives and expand the medical knowledge of end stage kidney disease(ESKD) especially for patients with SHPT
Figure 1. Clinical trial design
Funding
- Commercial Support – Kyowa Hakko Kirin (China) Pharmaceutical Co., Ltd.