Nemolizumab for Itching in Chronic Kidney Disease
(NIKAIA 1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing nemolizumab, a medication aimed at reducing itching. It focuses on adults undergoing hemodialysis who suffer from moderate to severe itching. The drug works by blocking a protein that triggers the itch sensation. Nemolizumab is a medication developed for treating various skin diseases, including itching associated with chronic kidney disease.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants must adhere to restrictions on certain medications before and during the study, so it's best to discuss your specific medications with the study team.
Is Nemolizumab safe for humans?
How is the drug Nemolizumab unique for treating itching in chronic kidney disease?
Nemolizumab is unique because it targets the interleukin-31 (IL-31) receptor, which is involved in causing itchiness, and is administered as an injection under the skin. This makes it different from other treatments that may not specifically target this pathway or use different administration methods.12346
What data supports the effectiveness of the drug Nemolizumab for itching in chronic kidney disease?
Nemolizumab has been shown to effectively reduce itching in conditions like atopic dermatitis by blocking a protein called interleukin-31 (IL-31), which is involved in causing itchiness. This suggests it might also help with itching in chronic kidney disease, as similar mechanisms could be involved.12347
Are You a Good Fit for This Trial?
Adults on hemodialysis for chronic kidney disease with moderate to severe itching (pruritus) lasting over three months can join. They must have a stable dialysis routine, no recent infections or hospitalizations for asthma, and not be pregnant or breastfeeding. Women able to have children must agree to use contraception or practice abstinence.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nemolizumab or placebo for 12 weeks to evaluate the efficacy in reducing pruritus intensity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nemolizumab
- Placebo
Nemolizumab is already approved in United States, European Union, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Galderma R&D
Lead Sponsor
Flemming Ørnskov
Galderma R&D
Chief Executive Officer since 2019
MD, MPH
Baldo Scassellati Sforzolini
Galderma R&D
Chief Medical Officer
MD, PhD