Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

PHASE3CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

May 18, 2023

Primary Completion Date

September 25, 2024

Study Completion Date

September 25, 2024

Conditions
Uremic Pruritus
Interventions
DRUG

Difelikefalin Injection

Participants receive Difelikefalin three times a week (0.5 micrograms/kg dry body weight). Difelikefalin is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis.

DRUG

Placebo Injection

Participants receive Placebo three times a week (0.5 micrograms/kg dry body weight). Placebo is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis.

Trial Locations (35)

Unknown

Investigator Site 25, Baotou

Investigator Site 01, Beijing

Investigator Site 07, Beijing

Investigator Site 26, Changsha

Investigator Site 06, Guangzhou

Investigator Site 12, Jiaxing

Investigator Site 02, Lanzhou

Investigator Site 34, Mianyang

Investigator Site 03, Nanjing

Investigator Site 10, Nanjing

Investigator Site 19, Nanjing

Investigator Site 36, Nantong

Investigator Site 40, Shanghai

Investigator Site 18, Shenyang

Investigator Site 21, Shenyang

Investigator Site 16, Shenzhen

Investigator Site 08, Shihezi

Investigator Site 32, Shijiazhuang

Investigator Site 41, Shijiazhuang

Investigator Site 20, Taiyuan

Investigator Site 24, Taiyuan

Investigator Site 39, Tianjin

Investigator Site 04, Ürümqi

Investigator Site 17, Wuhan

Investigator Site 33, Wuxi

Investigator Site 13, Xiamen

Investigator Site 15, Xianyang

Investigator Site 22, Xining

Investigator Site 38, Xinxiang

Investigator Site 11, Yangzhou

Investigator Site 30, Yibin

Investigator Site 29, Yinchuan

Investigator Site 23, Zhengzhou

Investigator Site 31, Zhenjiang

Investigator Site 35, Zhuzhou

All Listed Sponsors
collaborator

Tigermed Consulting Co., Ltd

INDUSTRY

lead

Vifor Fresenius Medical Care Renal Pharma

INDUSTRY

NCT05885737 - Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus | Biotech Hunter | Biotech Hunter