A 2-year, single-arm, multi-center study to explore the efficacy and safety of pegcetacoplan in preventing disease recurrence in adolescent and adult kidney transplant recipients with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis
C3 glomerulopathy (C3G) and primary IC-MPGN are rare conditions that damage the kidneys. Even after a patient receives a new donor kidney, these diseases can sometimes return and harm the new organ. This Phase 3 clinical trial is testing a medicine called pegcetacoplan (also known as Aspaveli) to see if it can prevent these diseases from coming back. The study involves adults aged 18 and over who need a kidney transplant because of C3G or IC-MPGN. Everyone taking part will receive the study medicine through an infusion under the skin. Doctors will follow participants closely for two years after their transplant. They will use regular blood tests, urine tests, and kidney tissue samples (biopsies) to see how well the new kidney is working and monitor for any side effects.
En un coup d'œil
De quoi parle cette étude ?
The kidneys play a vital role in filtering waste and extra fluid from your blood. In rare diseases like C3 glomerulopathy (C3G) and primary IC-MPGN, the body's immune system mistakenly attacks these filtering units. Over time, this damage can lead to kidney failure, meaning a person may need dialysis or a kidney transplant to stay well.
While a kidney transplant offers a fresh start, these conditions carry a risk of coming back in the new kidney. When the disease returns, it can damage the donor organ and cause it to fail. Currently, doctors have very few proven treatments to stop this from happening, which can be a major worry for people waiting for a transplant.
This trial is testing a medicine called pegcetacoplan to see if it can protect the new kidney. Pegcetacoplan works by calming down the specific part of the immune system that causes the damage. By studying patients for two years after their transplant, researchers hope to find out if this treatment is safe and effective at keeping the disease away for the long term.
Points clés
- Tests whether the medicine pegcetacoplan can stop C3G or IC-MPGN from returning after a transplant.
- Open to adults aged 18 and older who are preparing to receive a kidney transplant.
- Every participant receives the active study medicine; there is no placebo.
- Participants will be closely supported and monitored for two years with tests and biopsies.
- Taking part is voluntary, and you can withdraw at any time.
Qui peut être éligible ?
This study is open to adults aged 18 and older who have been diagnosed with either C3G or primary IC-MPGN. To take part, you must be currently planning or waiting to have a kidney transplant because your kidney condition has worsened.
Both men and women can join. Because this trial focuses specifically on preventing the disease from returning in a newly transplanted kidney, it is not suitable for people who are not planning to have a transplant in the near future.
Your hospital care team will also check your general health, medical history, and any other medications you take to make sure it is completely safe for you to take part.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- I am 18 years of age or older.
- I have been diagnosed with C3 glomerulopathy (C3G) or primary IC-MPGN.
- I am currently planning to have a kidney transplant.
- I am willing to receive regular medicine infusions.
- I am comfortable attending hospital appointments and having tests for two years.
En quoi consiste la participation ?
Taking part in this study lasts for about two years following your kidney transplant surgery. During this time, you will receive the study medicine, pegcetacoplan, as a liquid infusion. This is usually given under the skin using a small needle and pump, and the study team will train you or a carer on how to do this safely at home.
You will have regular hospital visits so the doctors can check on your recovery. These visits will involve standard health checks, such as measuring your blood pressure, taking blood samples, and checking your urine for signs of protein or blood. You will also have planned kidney biopsies, where a doctor takes a tiny sample of tissue from your new kidney to examine under a microscope. The study team will closely support you throughout the entire two-year follow-up period.
Risques et avantages potentiels
Emplacements (5)
- —Non vérifiéItalie
- —Non vérifiéFinlande
- —Non vérifiéFrance
- —Non vérifiéAllemagne
- —Non vérifiéEspagne
Questions fréquentes
What is pegcetacoplan?
It is a targeted medicine that calms down an overactive part of your immune system to help protect your kidneys from damage.
Will I definitely receive the study medicine?
Yes. This is a 'single-arm' trial, which means there is no dummy drug (placebo). Every participant receives the active medicine.
What is a kidney biopsy?
It is a routine procedure where a doctor uses a small needle to take a tiny sample of tissue from your kidney to check its health under a microscope.
Puis-je quitter l'étude si je change d'avis ?
Yes, you can leave the study at any time. Your normal medical care and transplant treatment will continue as usual.
Do I have to pay to take part?
No, clinical trials in the UK do not charge participants. The study medicine and trial-related tests are provided free of charge.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Discussion
Discussion communautaire
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