Your session is about to expire
← Back to Search
Nemolizumab for Itching in Chronic Kidney Disease (NemoCKDaP Trial)
NemoCKDaP Trial Summary
This trial will test if nemolizumab is better than placebo at reducing itchiness in adults with kidney disease who are on dialysis.
NemoCKDaP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNemoCKDaP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 226 Patients • NCT03100344NemoCKDaP Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- You don't follow the instructions for hemodialysis, according to the doctor.You have had issues with drinking alcohol or using drugs in the last six months.I have severe heart symptoms or had a heart attack in the last 3 months.I have severe kidney disease and have been on dialysis 3 times a week for 3 months.I have had itching for 3 months or more, with no cause found other than kidney disease.I haven't had cancer, except for specific skin or cervical cancers, in the last 5 years.I am scheduled for a major surgery or kidney transplant during the study.I have not followed or cannot follow medication restrictions.My pain level has been 5 or more out of 10 for the past week.I agree to not become pregnant or use birth control during and for 12 weeks after the study.I have not had COVID-19 in the last two weeks.I am using a reliable birth control method or my partner is sterile.You have tested positive for hepatitis B, hepatitis C, or HIV.My body weight is under 30 kg.I have itching due to a skin or systemic condition like eczema, psoriasis, or liver disease.You have a weakened immune system or get sick very often.I was hospitalized for asthma in the last year.I haven't had a skin infection or needed strong infection medicine in the last 2 weeks.I only experience itching during my dialysis sessions.My asthma symptoms have been frequent and disruptive in the last 3 months.My kidney dialysis is working well, meeting specific health standards.My asthma control score is 19 or less.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I need extra treatment for itchiness that started during screening or will need it soon.I have been treated with nemolizumab before.I have had a stroke or a mini-stroke in the last 6 months.I do not have active or untreated TB.Your blood tests show significant liver problems that could make it risky for you to take part in the study.I only experience itching in the palms of my hands.I cannot have children due to menopause or surgery.You have had a severe allergic reaction to an immunoglobulin product or any of the ingredients in the study drug.
- Group 1: Nemolizumab 30 mg
- Group 2: Nemolizumab 60 mg
- Group 3: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
At how many distinct sites is this clinical trial being conducted?
"Currently, this clinical trial is open to patients at Galderma Investigational Site 7038 in Fresh Meadows, New york, Galderma Investigational Site 7039 in Arlington, Texas, Galderma Investigational Site 7035 in Kansas City, Missouri, and 49 other locations."
What are the proposed benefits of this clinical trial?
"The objectives of this study are to assess the proportion of participants with an improvement in worst itch numeric rating scale (WI NRS) at week 12, and the secondary objectives include the proportion of participants with an improvement in sleep disturbance numeric rating scale (SD NRS) at week 4, the percentage of participants with an improvement in worst itch numeric rating scale (WI NRS) at week 12, and the proportion of participants with an improvement in worst itch numeric rating scale (WI NRS) at week 12."
How many study subjects are trialing this medication?
"252 participants that meet the eligibility requirements are necessary to run the study. The sponsor, Galderma R&D, will administer the trial from locations such as Galderma Investigational Site 7038 in Fresh Meadows, New york and Galderma Investigational Site 7039 in Arlington, Texas."
Could you provide more information on Nemolizumab's efficacy?
"There are currently 10 ongoing clinical trials for the efficacy of Nemolizumab. Of these, 7 are in Phase 3. The majority of these studies are taking place in Regensburg, Missouri, but there are 1161 locations total running these trials."
Could you please share whether this research project is still recruiting participants?
"Yes, this trial is still open and looking for patients. The original posting date was December 29th 2021, with the most recent edit on October 10th, 2022. They are recruiting 252 patients from 49 sites."
Will this be the first time this type of trial has been conducted?
"Nemolizumab has been under clinical investigation since 2019 when Galderma R&D first sponsored a study. Phase 3 clinical trials are only conducted once a drug has received initial approval from an earlier trial, of which there have been 750 in the case of Nemolizumab. Currently, there are 10 live trials being conducted in 237 cities and 25 countries."
Share this study with friends
Copy Link
Messenger