A Study of SHR0410 in Hemodialysis Patients With Pruritus

NCT ID: NCT04317209

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-17
• Study Completion Date: 2020-12-31

Brief Summary

The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus

Conditions

Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SHR0410 low dosage

Group Type: EXPERIMENTAL

SHR0410

Intervention Type: DRUG

administered intravenously

SHR0410 medium dosage

Group Type: EXPERIMENTAL

SHR0410

Intervention Type: DRUG

administered intravenously

SHR0410 high dosage

Group Type: EXPERIMENTAL

SHR0410

Intervention Type: DRUG

administered intravenously

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

administered intravenously

Interventions

SHR0410

administered intravenously

Intervention Type: DRUG

Placebo

administered intravenously

Intervention Type: DRUG

Other Intervention Names

KOR agonist

Eligibility Criteria

Inclusion Criteria

1. Males or females aged 18-65 (inclusive);

2. Weight (> 50 kg);

3. Patients with end-stage renal disease receiving hemodialysis (including hemodialysis and hemofiltration) three times a week for at least 3 months.

4. VAS≥4 at screening

Exclusion Criteria

1. New York cardiac function classification (NYHA) ≥ level III in the current or previous 6 months;

2. Pruritus caused by other than end-stage renal disease or its complications..

3. History of malignancy

4. Any physical or mental illness or condition, as determined by the study investigator, that may increase the risk of participating the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial

5. Positive urine drug screening; Or a history of drug abuse;

6. Urine test positive for nicotine;

7. Alcohol breath test positive;

8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or transglutaminase (GGT) was 1.5 times higher than the upper limit of normal value (ULN), or total bilirubin was 1.5 times higher than the upper limit of normal value (ULN);

9. Screening for hepatitis c antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody positive; Or hepatitis B is active;

10. Abnormal electrocardiogram considered inappropriate to participate in this study by the investigator

11. positive for human chorionic gonadotropin (hCG) blood test

12. A history of allergies to opioids

13. Has used opioids within one week prior to the current visit, or cannot avoid to use opioids other than the study drug during the study period;

14. Change the treatment regimen for pruritus within 14 days, or cannot avoid to change the treatment regimen for pruritus during the study period

15. Received Ultraviolet phototherapy within 14 days before screening visit; Or cannot avoid to receive ultraviolet light therapy during the study.

16. Change the treatment regimen of gabapentin, pregabalin, or duloxetine within 14 days before screening visit; Or the treatment regimen of gabapentin, pregabalin, or duloxetine cannot be avoided to be changed during the study period.

17. Change the treatment regimen of medications within 14 days that may affect the judgment of antipruritic effect; Or the treatment regimen cannot be avoided to be changed during the study

18. Using topical antipruritic drugs, such as creams and patches with moisturizing or antipruritic effects at present.

19. Kidney transplantation is expected during the study period;

20. Subjects who had Participated in this trial (defined by signing the informed consent);

21. Subjects who had Participated in clinical trials of any other drugs within the previous 3 months; Or plan to participate in other drug trials during the trial period;

22. Subjects who had Participated in the clinical trial of any medical device within the previous 3 months; Or participate in other medical device tests during the trial period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first affiliated hospital of sun yat-sen university

Guangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianjun Zou

Role: CONTACT

zoujianjun@hrglobe.cn

02168868570 ext. 02168868570

Li Yue

Role: CONTACT

yueli@hrglobe.cn

Facility Contacts

Wei Chen

Role: primary

Other Identifiers

SHR0410-103

Identifier Type: -

Identifier Source: org_study_id