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Abstract: PO0551

Interim Analysis of Paricalcitol vs. Cinacalcet in Hemodialysis Patients with Secondary Hyperparathyroidism: A Multicenter, Randomized, Positive Controlled Study (PERMIT Study)

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Qiao, Yingjin, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
  • Sun, Xiaoyan, Yantai Yeda Hospital, Yantai, China
  • Liu, Xinyu, Nanyang Central Hospital, Nanyang, China
  • Wang, Junxia, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China
  • Li, Jie, Yongchuan Hospital of Chongqing Medical University, Chongqing, Chongqing, China
  • Wang, Donghai, Zhumadian Central Hospital, Zhumadian, China
  • Zhang, Huazhen, Sanmenxia Central Hospital, Sanmenxia, China
  • Wang, Pei, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
  • Liu, Zhangsuo, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China

Group or Team Name

  • PERMIT study collaboration group
Background

A randomized, controlled, open-lable, multi-center study was conducted in China to compare the safety, efficacy and cost effectiveness of paricalcitol-dominated therapy with cinacalcet-dominated therapy in maintainted hemodialysis (MHD) patients with secondary hyperparathyroidism.

Methods

Patients over 18 years old, accepted MHD over 3 months, serum intact parathyroid hormone (iPTH)>300pg/mL, serum calcium 2.1~2.5mmol/L and serum phosphorus≤1.78mmol/L were randomized into paricalcitol-dominated therapy group (GpP) or cinacalcet-dominated therapy group (GpC) for 24 weeks. Paricalcitol or cinacalcet monotherapy was prescribed at the beginning, and combination therapy would be carried out when monotherapy was unable to meet the expected target for 2 consecutive visits (Fig 1). The primary endpoint was iPTH maintained within 150~300pg/mL. The secondary endpoints were the combination therapy rate, more than 30% or 50% decline of iPTH from baseline.

Results

271 patients in 23 centers were screened, 154 patients were enrolled and 93 patients completed the study up to May 2021. There was no statistical difference between groups in age, gender, iPTH, Ca and P at baseline. In GpP and GpC, 44.9% (22/49) vs 36.4% patients (16/44) achieved primary endpoint (P=0.406). 89.8% (44/49) vs 77.3% (34/44) and 73.5% (36/49) vs 63.6% (28/44) patients attained iPTH decline more than 30%(P=0.099)or 50% (P=0.306). 24.7% (19/77) patients in GpP have hypercalcemia, and 44.2% (34/77) patients in GpC have hypocalcemia. The incidences of hyperphosphatemia were similar (28.6% vs 26.0%, P=0.7174). Combination therapy rate had a rising tendency, 36.8% in GpP vs 59.1% in GpC.

Conclusion

Paricalcitol-dominated therapy was as effect as cinacalcet-dominated therapy with lower incidence of hypocalcemia and combination therapy rate. (chictr.org.cn registration number: ChiCTR2000031420)

Fig 1: Study Design