The MC2-25 Cream in Subjects wITh CHronic KIdNEy Disease-aSsociated prurituS (ITCHINESS) Trial

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