Clinical trials: Uremic Pruritis
Uremic Pruritus
Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis
This study is being conducted to investigate the efficacy of MT-9938 compared with placebo after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the effect of a reduction in itching intensity…
- Trial name
- NCT01660243
- Testing
- Nalfurafine hydrochloride(MT-9938) 2.5μg, Nalfurafine hydrochloride(MT-9938) 5μg, Nalfurafine hydrochloride(MT-9938) 10μg
- Where
- 4 sites in United States
- Volunteers
- 45 people
- Sponsor
- Toray Industries, Inc
Uremic Pruritus
A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet
This is a multisite study to evaluate the efficacy, safety and plasma concentration of Nalfurafine Hydrochloride orally disintegrating tablet in the treatment of refractory pruritus in maintenance hemodialysis patients, and to…
- Trial name
- NCT04728984
- Testing
- Nalfurafine Hydrochloride
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Uremic Pruritus, Pruritus
Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.
- Trial name
- NCT02143973
- Testing
- nalbuphine HCl ER
- Where
- 35 sites in United States
- Volunteers
- 167 people
- Sponsor
- Trevi Therapeutics
Uremic Pruritus
Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus.
- Trial name
- NCT02858726
- Testing
- CR845 0.5 mcg/kg, CR845 1 mcg/kg, CR845 1.5mcg/kg
- Where
- 29 sites in United States
- Volunteers
- 226 people
- Sponsor
- Cara Therapeutics, Inc.
Pruritus, Cholestasis
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.
- Conditions
- Pruritus, Cholestasis, Kidney Failure
- Trial name
- NCT04510090
- Testing
- EP547
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Escient Pharmaceuticals, Inc
Uremic Pruritus
Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
This a multicentre study that consists of a 12-week double-blind period, and an optional 14-week open-label extension period and a 1-week follow-up period.
- Trial name
- NCT05885737
- Testing
- Difelikefalin Injection
- Where
- 35 sites in China
- Volunteers
- 260 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
Uremic Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session.
- Trial name
- NCT03422653
- Testing
- CR845 0.5 mcg/kg
- Where
- 57 sites in United States
- Volunteers
- 378 people
- Sponsor
- Cara Therapeutics, Inc.
Uremic Pruritus
Phase 1 Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
This is a single-center clinical research study with the purpose to evaluate the safety, tolerability, and pharmacokinetics (PK) of nalbuphine HCl ER (extended release) tablets in end-stage renal disease (ESRD) patients receiving…
- Trial name
- NCT02373215
- Testing
- Nalbuphine HCL ER
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Trevi Therapeutics
Uremic Pruritus
Treatment of Uremic Pruritus With PA101B
This is a randomized, double blind, placebo-controlled, parallel-arm, multi-center, Phase 2, proof-of-concept efficacy and safety study in patients with end-stage renal disease requiring hemodialysis.
- Trial name
- NCT02696499
- Testing
- PA101B
- Where
- 13 sites in United States
- Volunteers
- 70 people
- Sponsor
- Patara Pharma
Uremic Pruritus
CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session.
- Trial name
- KALM-2 (NCT03636269)
- Testing
- CR845 0.5 mcg/kg
- Where
- 92 sites in United States, Australia and 9 more
- Volunteers
- 473 people
- Sponsor
- Cara Therapeutics, Inc.
Uremic Pruritus
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.
- Trial name
- NCT03998163
- Testing
- CR845 0.5 mcg/kg
- Where
- 47 sites in United States, Czechia and 2 more
- Volunteers
- 222 people
- Sponsor
- Cara Therapeutics, Inc.
Uremic Pruritus
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients…
- Trial name
- NCT05031546
- Testing
- Difelikefalin
- Sponsor
- Cara Therapeutics, Inc.
Uremic Pruritus
A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.
- Trial name
- NCT03802617
- Testing
- MR13A9
- Where
- Japan
- Volunteers
- 247 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Uremic Pruritus
Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.
- Trial name
- NCT03281538
- Testing
- CR845
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 288 people
- Sponsor
- Cara Therapeutics, Inc.
Uremic Pruritus
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of HSK21542 Injection in Subjects Undergoing Hemodialysis
This is a multi-center, randomized, double-blind, placebo-controlled phase II clinical trial. The main objective is to evaluate the safety, pharmacokinetics, and efficacy of HSK21542 injection in subjects undergoing hemodialysis
- Trial name
- NCT04470154
- Testing
- Stage I:HSK21542 0.05 μg/kg, Stage I:HSK21542 0.15 μg/kg, Stage I:HSK21542 0.30 μg/kg
- Where
- China
- Volunteers
- 131 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Chronic Kidney Diseases, Pruritus
CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in…
- Trial name
- NCT05356403
- Testing
- Difelikefalin 1 mg Oral Tablet
- Where
- 75 sites in United States, Argentina and 11 more
- Volunteers
- 105 people
- Sponsor
- Cara Therapeutics, Inc.
Uremic Pruritus
TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus
This study is a 2-part study. Part A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require…
- Trial name
- NCT03002233
- Testing
- TRK-820
- Where
- 2 sites in Bulgaria, Germany
- Volunteers
- 23 people
- Sponsor
- Toray Industries, Inc
Uremic Pruritus
AST-120 in Hemodialysis Patients With Uremic Pruritus
The prevalence of cutaneous pruritus among hemodialysis patients is about 50% to 80%. There is only a handful of studies on the itchy skin of hemodialysis patients and the findings are to be validated.
- Trial name
- AST-120 (NCT04639674)
- Testing
- AST-120
- Where
- 7 sites in Taiwan
- Volunteers
- 100 people
- Sponsor
- Conmed Pharmaceutical & Bio-Medical Corporation
Uremic Pruritus
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Double-blind, Placebo-controlled study to confirm the superiority of MR13A9 to placebo, and followed by extension, open-label treatment to confirm long-term safety of MA13A9 in hemodialysis patients with pruritus.
- Trial name
- NCT04711603
- Testing
- MR13A9
- Where
- Japan
- Volunteers
- 178 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Uremic Pruritus in Hemodialysis Patients
A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405 for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of treatment.
- Trial name
- NCT03218501
- Testing
- SK-1405 high dose, SK-1405 low dose
- Where
- Japan
- Volunteers
- 269 people
- Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.