Study on Efgartigimod for Patients with Antibody-Mediated Rejection after Kidney Transplant

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What is this study about?

This clinical trial is focused on studying a condition known as Antibody-Mediated Rejection, which can occur in individuals who have received a kidney transplant. This condition happens when the body’s immune system mistakenly attacks the transplanted kidney, thinking it is a foreign object. The study will test a treatment called Efgartigimod, which is given as a solution for injection using a pre-filled syringe. Efgartigimod is designed to help reduce the immune system’s attack on the transplanted kidney.

The purpose of the study is to evaluate the safety and tolerability of Efgartigimod in people who have experienced antibody-mediated rejection after a kidney transplant. Participants in the study will receive either Efgartigimod or a placebo, which looks like the treatment but does not contain the active medication. The study will be conducted over a period of time, during which participants will receive regular injections and attend follow-up visits to monitor their health and the effects of the treatment.

Throughout the study, various health assessments will be conducted, including checking for any side effects, monitoring kidney function, and measuring levels of certain proteins in the blood. The study aims to gather information on how well Efgartigimod works in managing antibody-mediated rejection and its overall impact on the health of kidney transplant recipients. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures of the trial. You will be asked to provide consent to participate.

You will be required to confirm that you meet the eligibility criteria, such as being between 18 and 80 years old, having had a kidney transplant at least 6 months ago, and having a diagnosis of active or chronic active antibody-mediated rejection.

2 initial assessment

An initial assessment will be conducted to evaluate your current health status. This may include laboratory tests, vital sign measurements, and an electrocardiogram (ECG).

Your current medications will be reviewed to ensure they meet the study requirements, such as having been on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks.

3 treatment administration

You will receive the study medication, efgartigimod, or a placebo through a subcutaneous injection using a prefilled syringe.

The dosage and frequency of administration will be determined by the study protocol, and you will be informed about the schedule.

4 ongoing monitoring

Throughout the study, you will be monitored for any side effects or adverse events. Regular check-ups will be scheduled to assess your health and the effectiveness of the treatment.

Laboratory tests, vital sign measurements, and ECGs will be conducted periodically to ensure your safety.

5 follow-up assessments

Follow-up assessments will be conducted to evaluate the impact of the treatment on your kidney function and overall health.

These assessments may include measuring changes in kidney biopsy results, urine protein levels, and serum IgG levels.

6 completion of the study

At the end of the study, a final assessment will be conducted to gather data on your health status and the outcomes of the treatment.

You will be informed about the results of the study and any further steps, if necessary.

Who Can Join the Study?

The participant is between the ages of 18 and 80 years old.
The participant had a kidney transplant (from a living or deceased donor) at least 6 months before the screening.
The participant has been diagnosed with active or chronic active antibody-mediated rejection (AMR) and has detectable donor-specific antibodies at the time of screening.
(Antibodies are proteins made by the immune system to fight infections. In this case, they are specific to the donor’s kidney.)
The participant may be allowed into the study if they have received the following medications:
- Received mycophenolate mofetil (MMF) for at least 20 weeks before screening.
  (MMF is a medication that helps prevent the body from rejecting a transplanted organ.)
- Has remained on a stable dose of mycophenolate mofetil (MMF) and tacrolimus (TAC) for at least 4 weeks before being allowed to participate in the study.
  (Tacrolimus is another medication used to prevent organ rejection.)
- Has remained on tacrolimus (TAC) doses between 5 to 10 ng/mL for at least 4 weeks before being allowed to participate in the study.
- The steroid dose was between 0 to 10 mg per day of prednisone (or an equivalent dose) for at least 4 weeks before being allowed to participate in the study.
  (Steroids like prednisone are used to reduce inflammation and help prevent organ rejection.)

Who Cannot Join the Study?

Patients who are not diagnosed with Antibody-Mediated Rejection cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not male or female cannot participate.
Patients who are not considered part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Medical University Of Vienna	Vienna	Austria
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Del Mar	Barcelona	Spain
Pellegrin Hospital	Bordeaux	France
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Uqakqyqlci Mvuntwa Cnfosp Hlkedhvpfwkfuhcex	Hamburg	Germany
Iwdmerubw Fwu Cgcnuxti Aed Eoleawhldoqy Mzqaywoh	Prague	Czechia
Hnykzaoo Vovh dqfcquiq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	11.11.2024
Belgium	Recruiting	11.11.2024
Czechia	Recruiting	11.11.2024
France	Recruiting	11.11.2024
Germany	Recruiting	11.11.2024
Spain	Recruiting	11.11.2024

Trial locations

Investigated drugs:

Efgartigimod Alfa

Efgartigimod PH20 SC is a medication being tested in this clinical trial. It is designed to help people who have received a kidney transplant and are experiencing a condition called antibody-mediated rejection (AMR). This condition occurs when the body’s immune system attacks the new kidney. Efgartigimod PH20 SC is given through a prefilled syringe and works by reducing the activity of certain antibodies in the body that are responsible for this rejection. The goal of the trial is to see if this medication is safe and well-tolerated by patients, and to understand how effective it is in helping to manage or reduce the rejection of the transplanted kidney.

Antibody-Mediated Rejection – Antibody-Mediated Rejection (AMR) is a condition that occurs when the immune system attacks a transplanted organ, such as a kidney, due to the presence of antibodies against the donor’s tissue. This immune response leads to inflammation and damage to the blood vessels in the transplanted organ. Over time, the ongoing immune attack can impair the function of the transplanted organ. The progression of AMR can vary, with some cases being acute and others chronic. Acute AMR can occur shortly after transplantation, while chronic AMR develops over a longer period. The condition requires careful monitoring to assess the extent of organ damage and immune activity.

Trial ID:

2023-508180-72-00

Protocol code:

ARGX-113-2302

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Efgartigimod for Patients with Antibody-Mediated Rejection after Kidney Transplant

What is this study about?

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