Table 1.

Summary characteristics of the included RCTs.

Study ID	Study design/phase	Blinding status	Country	Total number of participants	DFK			Duration of treatment	Main inclusion criteria	Primary outcome	Follow-up duration
					Dose	Route	Frequency
Fishbane et al. [8]	Multicenter RCT/phase 3	Double-blinded	United States	378	0.5 μg/kg	Intravenous	Three times per week for 12 weeks	12 Weeks	Eligible patients were adults (≥18 years of age) with ESKD who had been undergoing hemodialysis at least three times per week for at least 3 months and who had moderate-to-severe pruritus.	The percentage of patients who had an improvement (decrease) of at least 3 points from baseline at week 12 in the weekly mean score on the daily WI-NRS.	14 Weeks
Fishbane et al. [7]	Multicenter RCT/phase 2	Double-blinded	United States	89	0.5 μg/kg	Intravenous	Thrice weekly after each hemodialysis session for 8 weeks	8 Weeks	Male or female adults ≥18 years; patients with ESKD who have been on hemodialysis 3 times per week for at least 3 months before screening; persistent pruritus during the month before screening, with weekly mean WI-NRS score over the 7 days before randomization >4	Change from baseline at week 8 in the weekly mean of the 24-h daily WI-NRS score.	8 Weeks
Narita et al. [14]	Multicenter RCT/Phase 2	Double-blinded	Japan	124	0.5 μg/kg	Intravenous	Three times a week at the end of each hemodialysis session for 8 weeks	8 Weeks	Japanese male or female patients with ESKD and moderate to severe pruritus who were 20 years or older and undergoing maintenance hemodialysis 3 times a week for at least 12 weeks were enrolled in this trial.	Change from baseline in the weekly mean WI-NRS score at week 8.	8 Weeks
Narita et al. [13]	Multicenter RCT/Phase 3	Double-blinded	Japan	178	0.5 μg/kg	Intravenous	Three times per week intravenously for 6 weeks	6 Weeks	Japanese patients with ESKD of either sex with moderate to severe pruritus, 20 years of age who were undergoing maintenance hemodialysis three times a week for 12 weeks were enrolled in this trial.	Change from baseline in the WI-NRS score at week 4.	4 Weeks
Yosipovitch et al. [12]	Multicenter RCT/phase 2	Double-blinded	United States	133	0.5 mg	Oral	Once daily for 12 weeks	12 Weeks	The study enrolled adults (≥18 years) with CKD. Subjects who were not receiving HD had moderate renal impairment (stage 3 NDD-CKD) or severe renal impairment (stage 4–5 NDD-CKD). Subjects undergoing HD were receiving HD 3 times per week for ≥3 months before screening. had moderate-to-severe pruritus.	Change from baseline in the weekly mean of the daily WI-NRS scores at week 12.	12 Weeks

Note: RCT: randomized controlled trial; ESKD: end stage kidney disease; WI-NRS: Worst Itch Intensity Numerical Rating Scale; CKD: chronic kidney disease; HD: hemodialysis; NDD; non-dialysis dependent.