| Eligibility |
Inclusion Criteria:
- Adult males or non-pregnant females of any race or ethnicity who are = 18 years of age
at the time of screening
- Has provided written informed consent
- Chronic (>3 months) kidney disease (CKD) stages G3-G5 (i.e., estimated glomerular
filtration rate [eGFR] by CKD-EPI creatinine 2021 equation <60 mL/min/1.73 m2)
- Specifically for CKD subjects on haemodialysis (HD) or haemodiafiltration (HDF):
1. Subjects must be established on HD or HDF 3 times per week continuously for at
least 3 months prior to the start of screening and must not have plans to change
from HD to HDF or vice versa during the trial
2. Subjects who require an occasional additional HD or HDF treatment to manage fluid
overload may be enrolled as long as it is anticipated that no more than 4 such
treatments will be required in any given month
- At least moderate CKD-aP defined as WI-NRS =4
- Female subjects must be of either: a. Non-childbearing potential or b. Childbearing
potential
Exclusion Criteria:
- Has a functioning kidney transplant or is scheduled to receive a kidney transplant
during the trial (Note: subject can be on waiting list for kidney transplant)
- Subjects who receive peritoneal dialysis
- In the opinion of the investigator has pruritus attributed to a cause other than CKD
or its complications
- Has localized itch restricted to the palms of the hands
- Has concurrent skin conditions (including but not limited to pruritic dermatoses,
active skin infections, ulcerations) that may limit or prevent application of MC2-25
cream or MC2-25 vehicle or that may interfere with evaluation of the effects of MC2-25
cream or MC2-25 vehicle on the skin at the Screening or Baseline visits
- Subjects who will have skin biopsies performed must not have any known
hypersensitivity to the local anaesthetic or diagnosed bleeding disorders
- Has a concurrent or recent (within 12 months prior to screening) medical condition
that, in the opinion of the investigator, could pose undue risk to the subject, impede
completion of the trial procedures, or would compromise the validity of the trial
measurements
- Has a known current generalized infection (bacterial, viral, or fungal)
- Start of a new or change to existing systemic treatment for CKD-aP
- Use of emollients on CKD-aP areas within 10 days prior to the Baseline visit
- Use of any topical treatment on CKD-aP areas
- Use of any light therapy for CKD-aP
- Use of non-biologic systemic immunosuppressive treatment
- Use of biologic systemic treatment
- Subjects not currently on dialysis but who are likely to initiate routine dialysis
during participation in the trial
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