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Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients

This study aims to understand how the body manages iron in people undergoing kidney dialysis. When kidneys don't work properly, it can affect many body processes, including how much iron your body has and uses. Researchers want to look closely at certain hormones, called hepcidin and erythroferrone, which play a key role in controlling iron levels. These hormones aren't usually checked in dialysis clinics. The study will also explore how these iron-regulating hormones might be linked to your bone and calcium health, liver function, and any inflammation in your body. By understanding these connections better, doctors hope to improve care for dialysis patients in the future. Participating only involves having blood tests.

At a glance

Status
Recruiting
Sponsor
Ramsay Générale de Santé
Enrolment target
200
Start
01 Dec 2021
Estimated completion
01 Dec 2031

What is this study about?

This research study is designed to help us better understand how iron is processed in the bodies of people who are receiving haemodialysis for kidney failure. When kidneys are not working as they should, it can sometimes lead to problems with how the body handles important minerals like iron, as well as affecting other body systems.

The main goal is to study two specific substances in the blood, called hepcidin and erythroferrone. These substances are like messengers that help control how much iron your body absorbs, uses, and stores. Currently, doctors don't routinely check these levels in dialysis patients, so learning more about them could be very helpful. The study will also explore how these iron messengers might be connected to other important aspects of your health, such as your calcium and bone health, your liver function, and any inflammation you might have.

By carefully observing these connections, researchers hope to gain new knowledge about iron metabolism in dialysis patients. This deeper understanding could eventually lead to new ways to monitor and treat iron-related issues, helping to improve the overall health and well-being of people on haemodialysis. The information gathered will also be used to publish findings that can benefit the wider medical community.

Key takeaways

  • This study investigates iron in dialysis patients.
  • It focuses on specific iron-regulating hormones.
  • It also explores links to bone, liver, and inflammation.
  • Participation involves only blood tests during usual appointments.
  • Aims to improve future care for dialysis patients.

Who may be eligible?

To take part in this study, you must be an adult patient currently on dialysis. You also need to be able to understand what the study involves and provide your written agreement to participate. You must also be covered by the UK social security scheme or be eligible for its benefits.

There are certain reasons why you wouldn't be able to join. For example, if you are very unwell or frail, or if your blood's iron-carrying protein (haemoglobin) is very low (less than 7g/dl). You also can't take part if you have HIV, active hepatitis B or C, or if you are already involved in another clinical study that requires extra blood samples.

We also can't include pregnant or breastfeeding women, or anyone under legal protection like guardianship, or those who are in prison. This is to ensure that all participants are able to make their own informed decisions about taking part.

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.

  1. Are you an adult currently receiving kidney dialysis?
  2. Can you understand information about the study and agree to take part?
  3. Are you covered by a social security healthcare scheme?
  4. Do you feel generally stable and not extremely ill?
  5. Is your blood's iron-carrying protein (haemoglobin) usually above 7g/dl?
  6. Are you not currently pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement will be quite straightforward. It will mainly involve having blood tests. The study will follow your progress over time, and regular blood samples will be taken during your usual dialysis appointments. You will not need to take any new medications or attend extra clinic visits for this study. The total duration of your participation will depend on the study's design to track changes over time, but it will fit in with your existing treatment schedule.

Potential risks and benefits

Taking part in this study will help doctors learn more about iron management in dialysis patients, which could eventually lead to better care for you and others in the future. The main potential risk involves the blood tests, which are generally safe but may cause minor bruising or discomfort. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Hôpital Privé Claude Galien
    Verified postcode
    Quincy-sous-Sénart, France· Recruiting

Common questions

What exactly are hepcidin and erythroferrone?

These are natural substances (hormones) in your body that help control how your body uses and stores iron. They're like messengers that tell your body what to do with iron.

Will taking part involve extra appointments?

No, all blood tests will be taken during your usual dialysis appointments, so you won't need to make any extra visits.

Will this study change my current treatment for dialysis?

No, this is an observation study; it will not change your current treatment or medications. It aims to gather information.

How long will I be involved in the study?

The study will follow your progress over a period, but all your involvement, mainly blood tests, will be incorporated into your existing dialysis schedule.

What if I change my mind about participating?

You are free to stop participating in the study at any time, without giving a reason, and it will not affect your medical care.

How to find out more

Jean-François Oudet

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study of Markers of Iron Metabolism and Their Relationship W…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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