A Study of SHR0410 in Hemodialysis Patients With Pruritus

Last updated: May 21, 2020
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Rash

Skin Wounds

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT04317209
SHR0410-103
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Weight (> 50 kg);

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

  4. VAS≥4 at screening

Exclusion

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 compliancewith 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 totalbilirubin was 1.5 times higher than the upper limit of normal value (ULN);

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

  10. Abnormal electrocardiogram considered inappropriate to participate in this study bythe 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 useopioids other than the study drug during the study period;

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

  15. Received Ultraviolet phototherapy within 14 days before screening visit; Or cannotavoid to receive ultraviolet light therapy during the study.

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

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

  18. Using topical antipruritic drugs, such as creams and patches with moisturizing orantipruritic 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 theprevious 3 months; Or plan to participate in other drug trials during the trialperiod;

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

Study Design

Total Participants: 54
Study Start date:
May 17, 2020
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • The first affiliated hospital of sun yat-sen university

    Guangzhou,
    China

    Active - Recruiting

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