chronic kidney disease associated pruritus in haemodialysis patients
Conditions
Interventions
Experimental group:Difelikefalin intravenous injection solution
Sponsors
Children's Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The age of the subjects must be >=12 and =3 hours at least 2 weeks prior to screening. 3. The WI-NRS score of subjects during the 7-day lead-in period (the score recorded on the day the treatment starts will count as 8 days) meets the following two conditions: (1) the WI-NRS score has been recorded for at least 4 days during the 7-day lead-in period; (2) the average of the recorded WI-NRS scores >4.0 (moderate to severe itching); 4. Within the last 3 months prior to screening, subjects must have at least one of the following: (1) at least 2 single-pool Kt/V measurements >=1.2 on different dialysis days; (2) at least 2 urea reduction ratio measurements >=65% on different dialysis days; (3) one single-pool Kt/V measurement >=1.2 and one urea reduction ratio measurement >=65% on different dialysis days; 5. Prescribed dry weight >=20 kg; 6. Male and/or Female Contraceptive methods used by males and females should comply with local regulations regarding contraceptive methods for clinical research subjects. Male subjects: Subjects agree not to donate sperm from the first administration of difelikefalin (Day 1) until 7 days after the last administration of difelikefalin, and agree to use spermicidal condoms or to avoid heterosexual intercourse during the study period until 7 days after the last administration of difelikefalin. Female subjects: If the subject is of childbearing potential, the pregnancy test result at screening must be negative, they must not be breastfeeding, and they must agree to use adequate contraceptive measures (such as hormonal contraceptives, intrauterine devices, partner vasectomy, or true abstinence when aligned with the subject's preferences and usual lifestyle) from the date of informed consent until 7 days after the last administration of difelikefalin or according to local requirements (whichever is longer); Note: If the serum pregnancy test result at screening is uncertain due to elevated human chorionic gonadotropin levels secondary to ESRD and not related to pregnancy, a repeat serum pregnancy test may be conducted before Day 1 to confirm a negative result. 7. The subject and/or legal guardian (if needed) must provide an appropriately signed informed consent form (as described in Appendix 1 of Section 10.1), and where appropriate, provide a child’s consent form, both of which must comply with the ICF as
Exclusion criteria
Exclusion criteria: 1.Known to be non-compliant with HD treatments and deemed unlikely by the Investigator to complete the study (i.e., has a history of missed HD sessions due to non-adherence in the past 2 months); 2.Planned to receive a kidney transplant during the study. Note: being listed on a kidney transplant list is not an exclusion criterion; 3.Participants with itching caused by conditions other than chronic renal failure or complications of chronic renal failure, which could in the opinion of the Investigator affect the efficacy evaluation (e.g., atopic dermatitis, chronic urticaria). Note: participants whose pruritus is attributed to ESRD complications, such as hyperparathyroidism, hyperphosphataemia, anaemia, or the dialysis procedure or prescription may be enrolled; 4.Participants with localised itch restricted to the palms of the hands; 5.Participants with pruritus only during the dialysis session (by participant report); 6.Participants with known concurrent hepatic cirrhosis or severe hepatic impairment (e.g., Child-Pugh Class C); 7.Significant systolic or diastolic heart failure (e.g., New York Heart Association Class IV congestive heart failure); 8.Participants with concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ that has been excised or resected completely; 9.Severe mental illness or cognitive impairment (e.g., dementia) or other concurrent mental disorder that, in the opinion of the Investigator, would compromise the validity of study measurements; 10.Conditions associated with clinically important disruptions to the blood brain barrier (for example, primary brain malignancies, CNS metastases or other inflammatory conditions, active multiple sclerosis, advanced Alzheimer’s disease) that in the Investigator’s opinion may be associated with unacceptable risk for CNS effects; 11.Acute or unstable medical condition(s) that in the Investigator’s opinion, may be associated with increased risk to the participant, or may interfere with study assessments, outcomes, or the ability to provide written informed consent or comply with study procedures; 12.Participant is receiving ongoing ultraviolet B treatment and anticipates receiving such treatment during the study; 13.New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening. 14.New or change of prescription for opioids, gabapentin, or pregabalin within 14 days prior to screening; 15.Participant is receiving prohibited medication (e.g., nalfurafine hydrochloride, opioid antagonists) that cannot be stopped at least 14 days before enrolment in the study; 16.Participant has known hypersensitivity to the study intervention or any components of the difelikefalin formulation; 17.Known or suspected history of alcohol, narcotic, or other drug abuse or substance dependence within 12 months prior to screening or participant with any alcoholic beverage intake of more than two units per day more than once per week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of 0.5 µg/kg difelikefalin in HD adolescents (>=12 to <18 years) with moderate-to-severe pruritus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difelikefalin plasma concentration (Cpre);Difelikefalin plasma peak concentration (Cmax);Difelikefalin plasma valley concentration (C valley value); | — |
Countries
China
Contacts
Public ContactMao Jianhua
Zhejiang University School of Medicine Affiliated Children's Hospital
Outcome results
None listed