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Evaluation of MC2-25 Cream for Itching in Patients with Chronic Kidney Disease-associated Pruritus

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial aims to study the effectiveness and safety of MC2-25 cream compared to MC2-25 vehicle (the cream without the active ingredient) in treating chronic kidney disease-associated pruritus (CKD-aP). Pruritus refers to intense itching of the skin, which is a common and distressing symptom experienced by many people with chronic kidney disease. The condition can significantly impact quality of life and is often difficult to treat effectively with currently available options.

The purpose of the study is to determine if MC2-25 cream can reduce the severity of itching in adults who have kidney disease and suffer from persistent itching. The trial will last 12 weeks and will compare two groups of participants - one group will use the MC2-25 cream while the other will use the vehicle cream (placebo). Participants will need to record their itching intensity in a diary throughout the study period.

The study includes adult patients with moderate to severe itching who have chronic kidney disease stages G3-G5 (indicating moderate to severe kidney function impairment). Some participants may be receiving hemodialysis or hemodiafiltration, which are treatments that filter waste products from the blood when the kidneys can no longer perform this function adequately.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be randomly assigned to one of two groups. This process is called randomization. It ensures that each participant has an equal chance of receiving either the MC2-25 cream or the MC2-25 vehicle (placebo).
The trial is double-blind, meaning neither you nor the researchers will know which treatment you are receiving. This helps to ensure that the results are not biased.
Step 2
Baseline assessment
Before starting the treatment, a baseline assessment will be conducted. This involves recording your current symptoms and any other relevant health information.
You will be asked to complete a diary for 7 days prior to the baseline day, recording your symptoms to establish a starting point for the trial.
Step 3
Treatment phase
The treatment phase lasts for 12 weeks. During this time, you will apply the cream assigned to you. The cream is applied cutaneously, which means it is applied to the skin.
You will be instructed on how often and how much cream to apply. It is important to follow these instructions carefully to ensure the trial's accuracy.
Step 4
Weekly diary entries
Throughout the 12-week treatment phase, you will be required to keep a weekly diary. This diary will record your symptoms and any changes you experience.
The diary entries will help track the effectiveness of the treatment and any side effects you may encounter.
Step 5
End of treatment assessment
At the end of the 12-week period, a final assessment will be conducted. This will involve reviewing your diary entries and evaluating any changes in your symptoms.
The results will be compared to the baseline assessment to determine the effectiveness of the treatment.

Who can join the trial?

9 criteria

Adult males or non-pregnant females of any race or ethnicity who are 18 years or older at the time of screening.
Able to understand the trial and willing to comply with trial requirements.
Has provided written informed consent.
Has had chronic kidney disease for more than 3 months, specifically stages G3-G5, which means the kidneys are not working as well as they should (estimated glomerular filtration rate [eGFR] is less than 60 mL/min/1.73 m²).
For those on haemodialysis (HD) or haemodiafiltration (HDF): Must have been receiving HD or HDF 3 times per week continuously for at least 3 months before the start of screening, with at least the last 2 weeks being in-center dialysis. No plans to switch between HD and HDF during the trial. Occasional extra HD or HDF treatments are allowed if needed, but no more than 4 extra treatments in any month.
Has at least moderate chronic kidney disease-associated pruritus (CKD-aP), which means experiencing itching with a score of 4 or more on a specific scale (WI-NRS) over 7 days before the trial starts.
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Female participants must be either:
- Of non-childbearing potential, meaning they are postmenopausal (no periods for 12 months without another medical reason) or confirmed sterile (e.g., had surgery to remove uterus or ovaries).
- Of childbearing potential with a negative pregnancy test at the start of the trial.
- Female participants of childbearing potential must agree to use a highly effective method of contraception (less than 1% chance of failure per year) while receiving treatment in the trial.

Who cannot join the trial?

5 criteria

Patients who do not have Chronic Kidney Disease associated Pruritus cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are not male or female cannot participate.
Patients who are not considered part of a vulnerable population cannot participate.

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Verified sites

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Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
Responsive
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Lodz, Poland

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Investigated drugs

MC2-25 Cream is a topical treatment being tested for its ability to relieve itching in people with chronic kidney disease. This cream is applied directly to the skin and is designed to help reduce the discomfort and irritation caused by pruritus, which is a common issue for those with kidney problems. The trial aims to see how effective this cream is in easing the symptoms compared to a similar product without the active ingredient.

What is already known about the treatment

MC2-25 Cream – This medication is applied topically as a cream, meaning it is spread on the skin. It is currently being studied in clinical trials to determine its effectiveness and safety for treating itching associated with chronic kidney disease, known as chronic kidney disease-associated pruritus (CKD-aP). The main purpose of this cream is to relieve the persistent itching that patients with this condition experience. At the molecular level, the cream works by interacting with specific receptors in the skin to reduce the sensation of itchiness. It is classified as a dermatological agent, which means it is used to treat skin conditions.

Investigated diseases

Chronic Kidney Disease-associated Pruritus – This condition is characterized by persistent itching in individuals with chronic kidney disease. The itching can occur without any visible skin changes and is often widespread, affecting various parts of the body. It is believed to be related to the accumulation of toxins in the body due to impaired kidney function. The severity of the itching can vary, and it may be more intense at night, leading to sleep disturbances. Over time, the constant itching can lead to skin damage from scratching, which may result in secondary infections. The condition can significantly impact the quality of life, causing discomfort and distress.