ITCHINESS
Research type
Research Study
Full title
A Parallel-group (2-Arm), Randomized, Double-blind, 12 week Trial to Evaluate the Efficacy and Safety of MC2 25 Cream and MC2-25 Vehicle in Subjects with Chronic Kidney Disease-associated Pruritus (CKD aP)
IRAS ID
1004785
Contact name
Jon Bondebjerg
Contact email
Sponsor organisation
MC2 Therapeutics Ltd
Eudract number
2021-006971-40
ISRCTN Number
ISRCTN74524864
Research summary
Patients with chronic kidney disease are often suffering from pruritus (severe itching of the skin). This is mostly caused by the lack of correct kidney function and dialysis. The pruritus often presents with fluctuating intensity, often worse during nighttime than daytime, resulting in sleep disturbances. Most patients report itching over large, alternating, non-dermatomal regions of skin. The significant impact of itch on these patients’ quality of life is generally accepted. In 23,264 haemodialysis patients from 21 countries, the proportion of CKD patients on dialysis who are at least moderately bothered by self-reported pruritus is 37%, and 7% are extremely bothered. It has also been found that this itch was associated with higher risk for hospitalizations and death, higher rates of withdrawal from dialysis and missing scheduled dialysis treatments, and lower rates of employment. The itch in this patients The sponsor of this study has developed a new cream formulation which is deemed to reduce this the itch and therewith the associated complaints and disadvantages in dialysis patients.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
22/SW/0020
Date of REC Opinion
22 Mar 2022
REC opinion
Further Information Favourable Opinion