Status and phase
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Treatments
About
The purpose of this study is to access the efficacy and safety of MC2-25 cream and MC2-25 vehicle for treatment of chronic kidney disease associated pruritus (CKD)-aP).
Full description
In this trial, subjects who fulfil all inclusion and exclusion criteria are enrolled.
Eligible subjects will be randomised in a 2:1 ratio to MC2-25 cream or MC2-25 vehicle, respectively.
The subjects will apply the assigned investigational medicinal product (IMP) twice daily for 12 weeks.
Enrollment
Sex
Ages
Volunteers
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):
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
Primary purpose
Allocation
Interventional model
Masking
111 participants in 2 patient groups, including a placebo group
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Central trial contact
Maj Dinesen, MD
Data sourced from clinicaltrials.gov
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