Study on the Effectiveness and Safety of MC2-25 Cream for Itching in Chronic Kidney Disease Patients

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What is this study about?

This clinical trial is focused on studying a condition known as Chronic Kidney Disease-associated Pruritus (CKD-aP), which is a persistent itching that affects people with chronic kidney disease. The trial is testing a new treatment called MC2-25 cream, which contains the active ingredient alanyl glutamine. The study will compare the effects of this cream to a similar cream that does not contain the active ingredient, often referred to as a placebo.

The purpose of the study is to evaluate how effective and safe the MC2-25 cream is for people experiencing itching due to chronic kidney disease. Participants in the study will be randomly assigned to use either the MC2-25 cream or the placebo cream. The study will last for 12 weeks, during which participants will apply the cream to their skin as directed. Throughout the study, participants will be monitored to assess any changes in their symptoms and to ensure their safety.

This trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the MC2-25 cream and who is receiving the placebo. This approach helps to ensure that the results are unbiased and reliable. The main goal is to see if the MC2-25 cream can significantly reduce the itching experienced by participants compared to the placebo. Participants will be asked to keep a diary of their symptoms to help researchers measure the effectiveness of the treatment over the course of the study.

1 randomization and initial visit

Upon joining the trial, you will be randomly assigned to one of two groups. This means you will either receive the MC2-25 cream or a placebo cream that looks the same but does not contain the active ingredient.

During this visit, you will receive instructions on how to apply the cream and how often to use it. The cream is to be applied to the skin, as it is intended for cutaneous use.

2 treatment period

The treatment period lasts for 12 weeks. During this time, you will apply the cream as instructed. The frequency and dosage will be explained to you during the initial visit.

You will be asked to keep a diary to record your symptoms and any changes you notice. This will help in assessing the effectiveness of the treatment.

3 weekly diary entries

Each week, you will record your symptoms in a diary. This includes noting any changes in the intensity of your itching, using a scale provided to you.

These entries are important for tracking your progress and will be used to evaluate the treatment’s effectiveness.

4 follow-up visits

Throughout the trial, you will have scheduled follow-up visits. These visits are to monitor your health and ensure the treatment is proceeding safely.

During these visits, you may be asked about your diary entries and any side effects you might be experiencing.

5 end of trial

At the end of the 12-week period, you will have a final visit. This visit will include a review of your diary entries and an assessment of your overall experience during the trial.

The information collected will contribute to understanding the effectiveness and safety of the MC2-25 cream for treating chronic kidney disease-associated itching.

Who Can Join the Study?

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 chronic kidney disease (CKD) for more than 3 months, specifically stages G3-G5, which means the kidneys are not working as well as they should.
For CKD patients on haemodialysis (HD) or haemodiafiltration (HDF):

Must have been on 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.
Must not plan to switch between HD and HDF during the trial.
Can have occasional extra HD or HDF treatments for fluid overload, but no more than 4 extra treatments in any month.

Has at least moderate CKD-associated pruritus (itching), defined as a score of 4 or higher on a specific itch scale over 7 days before the trial starts.
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 reproductive organs).
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 while receiving treatment in the trial.

Who Cannot Join the Study?

Patients who are not adults cannot participate. This means you must be 18 years or older.
Patients who do not have Chronic Kidney Disease associated Pruritus cannot participate. This is a condition where people with chronic kidney disease experience itching.
Patients who are part of a vulnerable population may not be eligible. This includes groups who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland

Other Sites

Site Name	City	Country
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Johannes Wesling Klinikum Minden	Minden	Germany
Centrum Medyczne Med-Gastr Sp. z o.o.	Lodz	Poland
Szpital Matki Bozej Nieustającej Pomocy W Wolominie	Wołomin	Poland
Ngrc Nsao Bojvsr Sib Zmykwz	Bolszewo	Poland
Nsizbbv Bhorwiew Malgxfze Tsyqorld Hruovmsy	Lodz	Poland
Dbendicx Dypdpewh Kqsbzxh	Baja	Hungary
Bdqgocokubmqp Kgnwgedc Nkxffxpqyluqytptyelfwn ccnishku Dzkklmqb Ksafnkl	Szeged	Hungary
Sgogjkvlwjlx Kroulzlt Scmqvhse gkyju	Solingen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	28.10.2022
Hungary	Not recruiting	28.10.2022
Poland	Not recruiting	28.10.2022

Trial locations

Investigated drugs:

Alanyl Glutamine

MC2-25 Cream is a topical treatment being tested for its ability to relieve itching in people with chronic kidney disease. This condition, known as chronic kidney disease-associated pruritus, can cause severe itching that affects a person’s quality of life. The cream is applied directly to the skin, where it is intended to reduce the sensation of itchiness and provide relief to those suffering from this condition.

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 infections or other skin issues. The condition can significantly impact the quality of life, causing discomfort and emotional distress.

Trial ID:

2022-500044-38-01

Protocol code:

MC2-25-C1 /ITCHINESS

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of MC2-25 Cream for Itching in Chronic Kidney Disease Patients

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