RecruitingOBSERVATIONAL

LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration

This study is investigating how a kidney transplant from a living donor affects the person receiving the new kidney and the donor. We want to understand changes in kidney function, the body's defences (immune system), and the types of bacteria living in the gut. We'll be looking carefully at these things before the transplant and again 24 weeks afterwards. The study also measures body weight, blood pressure, and how the body uses different substances. The main goal is to get a clearer picture of how a kidney transplant impacts various parts of the body over time in both the donor and recipient, who live in the same house.

At a glance

Status

Recruiting

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

07 Feb 2023

Estimated completion

01 Nov 2026

Chronic Kidney Diseases

What is this study about?

This research is looking closely at people receiving a kidney transplant from a living donor, as well as the donors themselves. The main idea is to understand what happens to their bodies, especially their kidney function, their immune system (which fights off illness), and the bacteria in their gut. We know that these things can change after a kidney transplant, and by studying them together, scientists hope to learn more about how to make transplants even more successful in the future.

Researchers will collect information from participants before the transplant and then again about six months afterwards. This will help them see what changes occur over time. They will measure things like how well the kidney is working, body shape and weight, blood pressure, and will take samples to look at the immune system and the tiny organisms in the gut.

The findings from this study could help doctors better understand how the body reacts to a new kidney and how donors recover. This knowledge might eventually lead to better care for people having kidney transplants and could improve their long-term health.

Key takeaways

This study investigates how kidney transplants affect recipients and donors.
It focuses on kidney function, immune system, and gut bacteria.
Participation involves assessments before and 6 months after transplant.
No new medications are given; it's an observational study.
It aims to improve understanding of transplant outcomes.
Eligibility includes adults planning living kidney donation/transplantation.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 75 years old. You also need to be planning to either receive a kidney from a living donor or to donate a kidney to someone.

There are some reasons why you might not be able to join. For example, if you have certain serious health problems affecting your heart, lungs, liver, or kidneys (other than the kidney disease needing the transplant). You also can't take part if you've recently had surgery, have an active infection, or if your weight has changed a lot recently.

Additionally, if you are on a strict vegan diet or have known issues with drug or alcohol abuse, you would not be able to join this particular study.

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 between 18 and 75 years old?
Are you planning to receive or donate a living kidney?
Do you *not* have serious heart, lung, or liver illnesses?
Have you *not* had a significant weight change (more than 10%) in the last month?
Are you *not* on a vegan diet?
Do you *not* have an active infection currently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to come for several visits. These visits will happen before your kidney transplant and then again about 24 weeks (roughly six months) after the transplant. During these visits, the research team will check your kidney function, measure your blood pressure and body composition (like weight and body fat). They will also collect samples, such as blood and stool, to look at your immune system and the bacteria in your gut. You won't be given any new medications specifically for this study. The total duration of your active participation will be about six months after your transplant, in addition to the initial assessments before the procedure.

Potential risks and benefits

Taking part in this study may involve some benefits, such as contributing to medical knowledge that could improve future kidney transplants for everyone. You will also have your health monitored closely during the study. However, there are also some small risks, mainly from the blood and stool samples taken, which are generally safe procedures. You might feel a little discomfort or have bruising from blood draws. It's important to remember that participating in any study is completely voluntary, and you are free to withdraw at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Experimental and Clinical Research Center
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is 'multi-omics'?

It's a fancy term for looking at many different types of biological information at the same time, like genes, proteins, and gut bacteria, to get a full picture of what's happening in the body.

Do I need to take any special drugs for this study?

No, this study doesn't involve giving you any new medications. It's purely observational, meaning researchers are just looking at what naturally happens.

How long will I be involved in the study?

You'll be involved before your transplant and then for approximately 24 weeks (about six months) after the transplant for follow-up assessments.

What health conditions mean I can't join?

You cannot join if you have serious heart, lung, or liver problems, have a recent infection, or if your weight has changed significantly recently, among other things.

Will this study affect my usual kidney transplant care?

No, this study is designed to run alongside your standard medical care and will not interfere with your treatment plan for your transplant.

How to find out more

Hendrik Bartolomaeus, MD

hendrik.bartolomaeus@charite.de +49 30 450 540 464 Official trial record

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