Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Parallel-group (2-Arm), Randomized, Double-blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects with Chronic Kidney Disease-associated Pruritus (CKD-aP)

This research study is looking into a new cream, called MC2-25, designed to help people who experience persistent itching due to chronic kidney disease. We are comparing this new cream to a 'dummy' cream (a placebo) that looks the same but doesn't contain the active ingredient. The main goal is to see if MC2-25 can significantly reduce itching over a 12-week period, as reported by patients in their diaries. We also want to understand how many people experience a noticeable improvement or even a complete stop to their itching. This is an early-stage study (Phase II) to explore if the cream is effective and safe to use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Mc2 Therapeutics Limited

Enrolment target

Start

16 Jan 2023

Chronic Kidney Disease associated Pruritus

What is this study about?

Many people with long-term kidney problems experience uncomfortable itching, which can be difficult to manage. This constant itching is known as Chronic Kidney Disease-associated Pruritus, or CKD-aP. While there are some ways to help, researchers are always looking for better treatments.

This study is testing a new cream called MC2-25. We want to find out if this cream can effectively reduce the itching that people with kidney disease experience. To do this fairly, we're comparing it to a cream that looks exactly the same but doesn't have any active medication in it – this is called a 'placebo' or 'vehicle' cream. This helps us know if any improvements are truly because of the new medicine or just a result of applying any cream. Neither you nor your study doctor will know whether you are using the active cream or the placebo cream, which helps ensure the results are unbiased.

The study will last for 12 weeks. During this time, participants will regularly record their itching levels in a diary. By comparing the itching scores of people using the MC2-25 cream with those using the placebo cream, we can see if the new cream makes a real difference. We will also check if a certain number of people experience a big improvement or if their itching goes away completely. This is classed as a 'Phase II' study, meaning it's an early step to see if the treatment works and is safe before a larger study might be done.

Key takeaways

This study is testing a new cream (MC2-25) for itching caused by kidney disease.
It compares the new cream to a 'dummy' cream (placebo) over 12 weeks.
Your itching levels will be recorded in a diary.
It's a 'double-blind' study, meaning you won't know if you're getting the active or placebo cream.
The study helps researchers understand if the cream is effective and safe.
You can withdraw from the study at any time.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or older. We are looking for both men and women to join.

The most important thing is that you have been diagnosed with chronic kidney disease and are experiencing bothersome itching related to it. There will be other specific health checks to make sure this study is right and safe for you, and that you meet all the requirements. Your study doctor will discuss these with you in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have chronic kidney disease?
Are you experiencing itching because of your kidney disease?
Are you willing to apply a cream regularly for 12 weeks?
Are you able to attend clinic visits and keep a diary of your itching?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved for a total of 12 weeks. During this time, you would regularly apply the assigned cream (either MC2-25 or the placebo cream). You would also be asked to keep a diary of your itching levels each week. You will have several visits to the study clinic where the research team will monitor your health, check your itching, and make sure the cream is not causing any problems. These visits usually involve some questions, a physical check-up, and possibly some blood tests to keep an eye on your kidney health and overall well-being. The study team will explain exactly what each visit will involve and how often you'd need to come in.

Potential risks and benefits

Participating in this study might offer you the chance to try a new cream that could potentially help relieve your itching. However, as with any medication, there's a chance of side effects, though these are carefully monitored. It's important to remember that because you might receive a placebo cream, you might not experience any benefit from the study treatment. Your well-being is always the top priority, and you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary
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Unverified
Germany
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Unverified
Poland

Common questions

What does 'double-blind' mean?

It means neither you nor your study doctor will know if you're receiving the active cream or the placebo cream. This helps keep the results fair.

What is a 'placebo' cream?

A placebo cream looks exactly like the active cream but doesn't contain any medicine. It's used to compare against the active cream to see if the new medicine really works.

How long will I be in the study?

If you join, you will be part of the study for 12 weeks.

Will I still get my usual kidney disease treatment?

Yes, you will continue your standard treatment for chronic kidney disease throughout the study, unless the study doctor advises otherwise.

What happens if the cream doesn't help my itching?

Your study doctor will monitor your itching carefully. If the cream isn't helping, or if you have any concerns, they will discuss your options and ensure you receive appropriate care.