Phase 3 Study of SK-1403

NCT03801980 ↗

Phase 3 Completed 153 enrolled Sanwa Kagaku Kenkyusho Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.

Timeline

Start: 2019-01-21
Primary completion: 2019-12-17
Completion: 2019-12-21

Outcome

Met primary endpoint

paper The percentage of participants achieving mean serum iPTH concentrations of 60-240 pg/ml during the evaluation period was 67% (69/103) in the upacicalcet group and 8% (4/50) in the placebo group. PMID 37696667 ↗

paper The difference between the two groups was 59% (95% confidence interval, 48% to 71%). PMID 37696667 ↗

Publications

Shigematsu T, Koiwa F, Isaka Y, Fukagawa M, Hagita K, Watanabe YS, Honda D, Akizawa T. Efficacy and Safety of Upacicalcet in Hemodialysis Patients with Secondary Hyperparathyroidism: A Randomized Placebo-Controlled Trial. Clin J Am Soc Nephrol. 2023 Oct 1;18(10):1300-1309. doi: 10.2215/CJN.0000000000000253. Epub 2023 Sep 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	UPACICALCET	Small molecule	—	Intravenous