An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC‑MPGN
This research study is investigating a new medication called Pegcetacoplan for individuals who have developed specific kidney conditions, C3G or IC-MPGN, following a kidney transplant. These conditions cause damage to the filtering parts of the kidney. The main goal is to find out if Pegcetacoplan can reduce the amount of harmful C3c protein deposits in the kidneys after 12 weeks of treatment, which is measured with a kidney biopsy. Researchers will also check its safety and how it affects kidney function over a longer period, up to 52 weeks. This is a Phase 2 study, meaning it's an earlier stage of testing to see if the treatment works and is safe enough for further investigation, helping us understand more about managing these complex kidney issues.
At a glance
What is this study about?
This study is about a new medicine called Pegcetacoplan. It's for people who have specific kidney problems, C3G or IC-MPGN, that have come back after they've had a kidney transplant. These conditions can cause damage to the tiny filters in your kidneys, affecting how well they work. The aim of this research is to see if this new medicine can help reduce the harmful deposits that build up in the kidney and to make sure it's safe.
Researchers will be giving the medicine as an infusion (through a drip) over several months. To check how well the medicine is working, they will look at samples taken during a kidney biopsy. They want to see if the amount of a substance called C3c, which is linked to these kidney problems, goes down after 12 weeks of treatment. They will also keep an eye on your kidney's overall health and how it's working by doing blood tests over a longer period, up to 52 weeks.
This is a 'Phase 2' study. This means it's an important step to see if the medicine is effective and safe enough to be studied in a larger group of people later on. The information gathered from this study will help doctors understand if Pegcetacoplan could be a useful new treatment option for people facing these particular kidney challenges after a transplant.
Key takeaways
- This study is testing a new medicine for specific kidney problems after a transplant.
- It aims to see if the medicine reduces harmful deposits in the kidney and is safe.
- Participation involves regular clinic visits for infusions and health checks.
- Kidney biopsies will be part of the assessment process.
- The study lasts for up to 52 weeks, with active treatment for 12 weeks.
Who may be eligible?
To join this study, participants must be at least 18 years old. Both men and women can take part.
There will be other, more detailed requirements that the study team will discuss with you. These usually include things like specific health conditions you must have, other medications you might be taking, and your general health condition.
It's important to talk to your doctor or the study team to find out if this study might be right for you and if you meet all the necessary criteria.
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 at least 18 years old?
- Do you have C3G or IC-MPGN that has returned after a kidney transplant?
- Are you able to attend regular clinic visits for treatment and check-ups?
- Are you willing to have kidney biopsies as part of the study?
- Are you open to trying a potential new treatment?
What does participation involve?
If you decide to take part in this study, you will receive the study medicine, Pegcetacoplan, as an infusion (through a drip) at regular intervals. This means you would need to visit the clinic for these treatments.
To see how the medicine is working and to monitor your health, you'll have several assessments throughout the study. These will include blood tests to check your kidney function and general health, and regular check-ups. You will also have kidney biopsies at the start of the study and after 12 weeks of treatment to examine the kidney tissue directly.
Researchers will also monitor any side effects you might experience. The total duration of the active treatment phase will be 12 weeks, but your health will be followed for a longer period, up to 52 weeks, to see the long-term effects of the medicine.
Potential risks and benefits
Locations (3)
- —UnverifiedNetherlands
- —UnverifiedAustria
- —UnverifiedItaly
Common questions
What are C3G and IC-MPGN?
These are kidney conditions that damage the filters in your kidneys, which can cause kidney problems after a kidney transplant.
What is Pegcetacoplan?
It's a new medicine being studied to see if it can help treat C3G or IC-MPGN that returns after a kidney transplant.
How will the medicine be given?
The medicine will be given as an infusion, which means through a drip, at planned visits to the clinic.
How long will the study last?
The main treatment part of the study is 12 weeks, but your health will be followed for up to 52 weeks in total.
Will I need to have a kidney biopsy?
Yes, you will have a kidney biopsy at the beginning of the study and after 12 weeks of treatment to check how the medicine is working.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.