Ongoing Clinical Trials for Chronic Kidney Disease-associated Pruritus
There are currently 2 clinical trials investigating new treatments for people experiencing persistent itching related to chronic kidney disease. These studies are taking place in Germany, Hungary, and Poland, and are testing a cream called MC2-25 to see if it can effectively reduce the distressing symptoms of itching that many kidney disease patients experience.
Clinical trial locations
- Germany
- Hungary
- Poland
Evaluation of MC2-25 Cream for Itching in Patients with Chronic Kidney Disease-associated Pruritus
This trial is investigating MC2-25 cream as a potential treatment for the intense itching that many people with chronic kidney disease experience. The condition, known as chronic kidney disease-associated pruritus, can significantly affect quality of life and is often difficult to treat with currently available options.
Who can participate:
- Adults 18 years or older of any race or ethnicity
- People with chronic kidney disease stages G3-G5 (meaning the kidneys are not working as well as they should, with an estimated glomerular filtration rate less than 60 mL/min/1.73 m²) for more than 3 months
- Those experiencing at least moderate itching, with a score of 4 or more on a specific itching scale over 7 days
- For those on hemodialysis or hemodiafiltration: must have been receiving treatment 3 times per week continuously for at least 3 months, with at least the last 2 weeks being in-center dialysis
- Female participants of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception during the trial
Who cannot participate:
- People who do not have chronic kidney disease-associated itching
- Those younger than 18 years old
- Individuals not meeting the specified clinical trial requirements
What the trial involves:
The study lasts 12 weeks and compares MC2-25 cream to a vehicle cream (the same cream without the active ingredient, also called a placebo). Participants will be randomly assigned to one of these two groups in a double-blind design, meaning neither participants nor researchers will know who is receiving which treatment. This helps ensure unbiased results.
Throughout the study, participants will apply the cream to their skin as directed and keep a weekly diary recording their itching intensity and symptoms. Before treatment begins, participants will complete a 7-day diary to establish a baseline. At the end of 12 weeks, researchers will compare the final results to this baseline to determine if the treatment was effective.
Investigational treatment:
MC2-25 Cream is applied directly to the skin and is designed to reduce the discomfort and irritation caused by itching. The trial aims to determine if this cream is more effective than the placebo in easing symptoms.
Study on the Effectiveness and Safety of MC2-25 Cream for Itching in Chronic Kidney Disease Patients
This clinical trial is also focused on testing MC2-25 cream, which contains the active ingredient alanyl glutamine, as a treatment for persistent itching in people with chronic kidney disease. The study will compare this cream to a placebo cream to evaluate both effectiveness and safety.
Who can participate:
- Adults 18 years or older of any race or ethnicity
- People with chronic kidney disease stages G3-G5 for more than 3 months
- Those experiencing at least moderate itching, defined as a score of 4 or higher on a specific itch scale over 7 days before the trial starts
- For those on hemodialysis or hemodiafiltration: must have been on treatment 3 times per week continuously for at least 3 months before screening, with at least the last 2 weeks being in-center dialysis, and should not plan to switch between hemodialysis and hemodiafiltration during the trial
- Female participants of childbearing potential must have a negative pregnancy test at the start and agree to use highly effective contraception during treatment
Who cannot participate:
- People younger than 18 years old
- Those who do not have chronic kidney disease-associated itching
- Members of vulnerable populations who might need special protection or care
What the trial involves:
Participants will be randomly assigned to receive either MC2-25 cream or a placebo cream for 12 weeks. The study is double-blind, meaning neither participants nor researchers will know who receives which treatment, ensuring unbiased results. During the initial visit, participants will receive instructions on how to apply the cream and how often to use it.
Throughout the 12-week treatment period, participants will keep a weekly diary to record their symptoms and any changes in itching intensity using a provided scale. There will be scheduled follow-up visits to monitor health and ensure the treatment is proceeding safely. At the end of the trial, researchers will review diary entries and assess the overall experience to understand the cream’s effectiveness and safety.
Investigational treatment:
MC2-25 Cream is applied directly to the skin and works by interacting with specific receptors in the skin to reduce the sensation of itchiness. The goal is to provide relief to those suffering from this distressing condition and improve their quality of life.
Summary
Both ongoing trials are investigating the same treatment, MC2-25 cream, for chronic kidney disease-associated itching. The trials are being conducted across three European countries: Germany, Hungary, and Poland, indicating international collaboration in finding solutions for this distressing condition.
Both studies follow a similar design with a 12-week treatment period, double-blind randomization, and comparison to placebo. They target adults with moderate to severe kidney disease (stages G3-G5) who experience at least moderate itching. The trials accept participants both with and without dialysis treatment, though those on dialysis must have stable treatment schedules.
The focus on MC2-25 cream across both trials suggests this is a promising investigational treatment for a condition that currently has limited effective treatment options. The persistent itching associated with chronic kidney disease can significantly impact quality of life, causing sleep disturbances, skin damage from scratching, and emotional distress. These trials represent important steps in finding better solutions for patients experiencing this difficult symptom.