Not recruitingRare disease

A study testing ALXN2030 for adults with antibody-mediated rejection after kidney transplantation

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves adults who have experienced antibody-mediated rejection after receiving a kidney transplant. Antibody-mediated rejection is a condition where the body's immune system produces antibodies that attack the transplanted kidney, which can lead to damage and potential loss of the transplanted organ. The study will test a medication called ALXN2030, which is given as an injection into a vein, under the skin, or into a muscle. Some participants will receive ALXN2030 while others will receive a placebo. The goal of the study is to find out if ALXN2030 is effective at resolving the rejection process as seen on kidney tissue samples taken through biopsy at week 52 compared to placebo.

During the study, participants will receive treatment for up to 104 weeks. The maximum daily dose of ALXN2030 that may be given is 450 milligrams. The study will examine whether the medication can help resolve the signs of rejection seen in kidney tissue samples, improve kidney function as measured by a blood test called estimated glomerular filtration rate, and reduce the activity of the rejection process. Before starting the study medication, all participants must be vaccinated against certain bacterial infections including meningococcal infection, pneumococcal infection, and Haemophilus influenzae type B infection, as the study medication may affect the immune system.

Throughout the study, doctors will monitor participants for any side effects or unwanted reactions to the treatment. They will also measure the amount of ALXN2030 in the blood over time and check if the body develops any antibodies against the study medication. The study will also track changes in certain proteins and immune system activity in the blood to understand how the medication works in the body. Kidney tissue samples will be taken at specific times during the study to assess whether the rejection process has improved or resolved.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Vaccination requirements
Before receiving the first dose of the study medication, vaccination against meningococcal infection (a serious bacterial infection) for types A, C, W, Y, and B (where available) is required. This vaccination must be completed at least 14 days before starting the study medication, but not more than 3 years before.
If the vaccination is given less than 14 days before starting the study medication, prophylactic antibiotics (antibiotics taken to prevent infection) will be provided for at least 14 days after vaccination.
Vaccination against Streptococcus pneumoniae (a bacteria that can cause pneumonia and other infections) is required before being assigned to a treatment group, following current vaccination guidelines.
Vaccination against Haemophilus influenzae type B (a bacteria that can cause serious infections) is required before being assigned to a treatment group, where available and according to current vaccination guidelines.
Step 2
Screening and kidney biopsy
A kidney biopsy (a procedure where a small sample of kidney tissue is removed for examination) will be performed during the screening period to confirm the diagnosis of active or chronic active antibody-mediated rejection (a condition where the immune system attacks the transplanted kidney).
The biopsy will be examined to determine the histologic score (a measure of tissue damage) and confirm eligibility for the study.
Body weight and eGFR (estimated glomerular filtration rate, a measure of kidney function) will be assessed during screening.
Step 3
Randomization and treatment assignment
After completing all screening procedures and meeting eligibility requirements, assignment to one of two treatment groups will occur randomly.
One group will receive ALXN2030, and the other group will receive placebo (an inactive substance that looks like the study medication but contains no active ingredients).
This is a double-blind study, meaning neither the patient nor the medical staff will know which treatment is being received.
Step 4
Study medication administration
The study medication (either ALXN2030 or placebo) will be administered as a solution for injection.
The medication may be given through one of the following routes: intravenous (into a vein), subcutaneous (under the skin), or intramuscular (into a muscle).
Treatment will continue for 52 weeks (approximately one year).
Step 5
Week 28 assessment
At Week 28, a kidney biopsy will be performed to assess histologic resolution (improvement in tissue damage) and resolution of antibody-mediated rejection activity.
Kidney function will be measured through eGFR testing.
Blood samples will be collected to measure plasma concentration of the study medication, C3 protein levels (a component of the immune system), and serum complement functional activity (a measure of immune system function).
Step 6
Week 52 assessment
At Week 52, another kidney biopsy will be performed to assess histologic resolution and resolution of antibody-mediated rejection activity.
Kidney function will be measured through eGFR testing to determine changes from the beginning of the study.
The annualized eGFR slope (the rate of change in kidney function over time) will be calculated for the entire 52-week treatment period.
Blood samples will be collected to measure plasma concentration of the study medication, C3 protein levels, and serum complement functional activity.
Testing for anti-ALXN2030 antibodies (antibodies that the body may develop against the study medication) will be performed.
Step 7
Safety monitoring throughout the study
Throughout the entire study period, monitoring for treatment-emergent adverse events (any unwanted medical occurrences that happen during treatment) and treatment-emergent serious adverse events (severe medical occurrences that require hospitalization or are life-threatening) will occur.
Regular blood samples will be taken at various time points to monitor the levels of study medication and immune system components in the blood.
Kidney function will be monitored regularly through eGFR measurements.
Step 8
Contraception requirements
If applicable, specific contraception methods (birth control) must be followed throughout the study period as specified in the study protocol.
Both patients capable of becoming pregnant and their partners must follow the contraception guidance provided.

Who can join the trial?

12 criteria

You must be between 18 and 75 years old at the time you sign the consent form
You must receive vaccines against meningococcal infection (a serious bacterial infection that affects the brain and spinal cord covering) for types A, C, W, Y, and B if available. These vaccines must be given at least 14 days before starting the study treatment, but not more than 3 years before. If you get vaccinated less than 14 days before starting, you will need to take preventive antibiotics (medicines to prevent infection) for at least 14 days after vaccination. You must agree to get vaccinated again as recommended by your local health guidelines
You must receive a vaccine against pneumococcal infection (a bacterial infection that can cause pneumonia and other serious illnesses) before being assigned to the study, following your local health guidelines
You must receive a vaccine against Haemophilus influenzae type B (a bacterial infection) if available in your area, before being assigned to the study, following your local health guidelines. If vaccination is not recommended for you because your body cannot respond to vaccines properly, you may need to take preventive antibiotics instead
You must have received your kidney transplant (surgical procedure where a donated kidney is placed in your body) at least 6 months before the initial study visit
You must have a confirmed diagnosis of active or chronic active antibody-mediated rejection (a condition where your immune system attacks the transplanted kidney) based on a kidney biopsy (a procedure where a small piece of kidney tissue is removed and examined) using the Banff 2022 classification system
Your kidney biopsy must show specific damage with a histologic score (tissue damage rating) of at least 2, meaning there is inflammation in certain parts of the kidney blood vessels
Your estimated glomerular filtration rate or eGFR (a blood test that measures how well your kidneys are filtering waste) must be at least 30 milliliters per minute per 1.73 square meters of body surface area
You must weigh at least 50 kilograms (about 110 pounds)
The study is open to all genders and gender identities, including males and females assigned at birth
If you or your partner are able to become pregnant, you must follow the birth control methods specified in the study protocol
You must sign the informed consent form (a document that explains the study) and agree to follow all study requirements and restrictions

Who cannot join the trial?

4 criteria

The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why someone cannot participate are not available in this data
Generally, clinical trials have exclusion criteria to ensure patient safety and study accuracy, but these specific details would need to be obtained from the complete study documentation
If you have received a kidney transplant and are experiencing antibody-mediated rejection (a condition where your body's immune system attacks the transplanted kidney), you should discuss with your transplant doctor whether this study might be appropriate for you
Your doctor will review all necessary medical requirements and restrictions to determine if you can safely participate in this research

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Verified sites

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Verified
Hospital Del Mar
Barcelona, Spain
Verified
Hospital Vall d’Hebron
Barcelona, Spain

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Investigated drugs

ALXN2030 is an investigational medication being tested in this clinical trial. It is being studied to see if it can help adults who are experiencing antibody-mediated rejection after receiving a kidney transplant. Antibody-mediated rejection happens when the body's immune system produces antibodies that attack the transplanted kidney. This medication is being compared to a placebo (an inactive substance) to determine if it can help resolve the rejection and protect the transplanted kidney. The study will examine whether ALXN2030 is effective and safe for patients experiencing this type of rejection.

RNA, (AM-SP-UM-CM-AM-AM-CM-UM-(2'-DEOXY-2'-FLUORO)C-(2'-DEOXY-2'-FLUORO)A-(2'-DEOXY-2'-FLUORO)C-(2'-DEOXY-2'-FLUORO)C-UM-GM-UM-AM-AM-UM-AM-AM-AM-GM-CM-AM-GM-CM-CM-GM-[2'-O-[[2-[2-[[5-[[2-(ACETYLAMINO)-2-DEOXY-BETA-D-GALACTOPYRANOSYL]OXY]-1-OXOPENTYL]AMINO]ETHOXY]ETHOXY]METHYL]]A-[2'-O-[[2-[2-[[5-[[2-(ACETYLAMINO)-2-DEOXY-BETA-D-GALACTOPYRANOSYL]OXY]-1-OXOPENTYL]AMINO]ETHOXY]ETHOXY]METHYL]]A-[2'-O-[[2-[2-[[5-[[2-(ACETYLAMINO)-2-DEOXY-BETA-D-GALACTOPYRANOSYL]OXY]-1-OXOPENTYL]AMINO]ETHOXY]ETHOXY]METHYL]]A-GM-GM-CM-UM-GM-CM), COMPLEX WITH RNA ([4'-DE(HYDROXYMETHYL)-4'-[(HYDROXYMETHOXYPHOSPHINYL)METHOXY]]UM-SP-(2'-DEOXY-2'-FLUORO)U-SP-(2'-DEOXY-2'-FLUORO)U-(2'-DEOXY-2'-FLUORO)A-(2'-DEOXY-2'-FLUORO)U-UM-(2'-DEOXY-2'-FLUORO)A-CM-AM-(2'-DEOXY-2'-FLUORO)G-GM-UM-GM-(2'-DEOXY-2'-FLUORO)A-GM-UM-UM-GM-AM-UM-SP-GM-SP-GM)

What is already known about the treatment

ALXN2030 – ALXN2030 is an investigational medication currently being studied in clinical trials and is not yet approved for general medical use. It is being tested as a treatment for antibody-mediated rejection, a serious complication that can occur after kidney transplantation when the recipient's immune system produces antibodies that attack the transplanted kidney. The medication works by targeting specific molecules involved in the immune response that causes this rejection, though the exact molecular mechanism is still under investigation in the Phase 2 trial. ALXN2030 is administered under controlled clinical trial conditions to evaluate whether it can help resolve the tissue damage caused by antibody attacks and protect the transplanted kidney from further harm.

Investigated diseases

Antibody-Mediated Rejection after Kidney Transplantation – This condition occurs when the body's immune system produces antibodies that attack a transplanted kidney, recognizing it as foreign tissue. The antibodies target the blood vessels in the donated kidney, causing inflammation and damage to the organ. This rejection can happen in two forms: active rejection, which develops quickly with sudden symptoms, or chronic active rejection, which progresses slowly over months or years. The immune attack leads to scarring of the kidney tissue and gradual loss of kidney function. As the condition advances, the transplanted kidney becomes less able to filter waste products from the blood. Without proper management, the ongoing antibody response continues to damage the kidney, potentially leading to complete loss of the transplanted organ's function.