ALXN2030 for Rejection After Kidney Transplant

(CONCORD Trial)

Recruiting at 46 trial locations

Overseen By Alexion Pharmaceuticals, Inc. (Sponsor)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alexion Pharmaceuticals, Inc.

Must not be taking: Antiretrovirals, Hepatitis treatments

Disqualifiers: HIV, Hepatitis B/C, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 28

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the effectiveness of ALXN2030, an experimental treatment, for individuals who have undergone a kidney transplant and are experiencing antibody-mediated rejection, an immune response against the transplanted kidney. The study compares two different doses of ALXN2030 with a placebo to determine if it can resolve rejection issues over a year. Individuals who received a kidney transplant over six months ago and are experiencing active rejection that impacts their daily lives might be suitable candidates for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, it mentions that standard care treatment should be stable during the entire treatment, suggesting you may need to maintain your current medications if they are part of your standard care.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ALXN2030 is being tested for safety in individuals who have had a kidney transplant. In earlier studies, researchers examined whether this drug could reduce the risk of the body rejecting the new kidney. Although ALXN2030 is still under investigation, its progression to Phase 2 suggests that early safety results are promising enough to warrant further testing.

In this phase, researchers assess how well participants tolerate the drug and identify any potential side effects. While detailed safety data on ALXN2030 from these studies is not yet available, treatments reaching this stage typically have demonstrated a reasonable safety profile in earlier tests. Prospective trial participants should discuss the potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ALXN2030 because it takes a novel approach to tackling kidney transplant rejection by targeting specific pathways involved in the immune response. Unlike current standard treatments, which often involve broadly suppressing the immune system with drugs like corticosteroids or calcineurin inhibitors, ALXN2030 aims to precisely modulate the immune system, potentially reducing side effects and improving outcomes. The treatment is offered in two different doses, Dose A and Dose B, allowing for flexibility and optimization of therapy depending on individual patient needs. This targeted mechanism offers hope for a more tailored and effective solution to prevent organ rejection, promising a significant advancement over existing therapies.

What evidence suggests that this trial's treatments could be effective for rejection after kidney transplant?

Research has shown that ALXN2030 is being tested for its potential to help with antibody-mediated rejection (AMR) after a kidney transplant. This condition occurs when the body's immune system attacks the new kidney. In this trial, participants will receive either ALXN2030 at different doses or a placebo. ALXN2030 aims to lower this immune response, potentially improving the transplanted kidney's function over time. Early results suggest that ALXN2030 could prevent rejection by affecting specific parts of the immune system. While detailed results from human trials are still being gathered, this approach appears promising based on its intended mechanism. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for kidney transplant recipients experiencing active or chronic active antibody-mediated rejection. Specific eligibility details are not provided, but typically participants must meet certain health criteria and agree to follow study procedures.

Inclusion Criteria

eGFR ≥ 30 mL/min/1.73 m2

MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)

I have been vaccinated for H. influenzae type B.

Exclusion Criteria

Biopsy-based diagnosis of Glomerulonephritis

Platelets < 100 × 10^9/L

Leucocytes < 3 × 10^9/L

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Treatment

Participants receive ALXN2030 Dose A, ALXN2030 Dose B, or placebo for 52 weeks with standard immunosuppressive treatment

52 weeks

Biopsies at 28 and 52 weeks

Open-Label Extension

Participants may continue treatment with ALXN2030 for an additional 52 weeks

52 weeks

Safety Follow-Up

Participants are monitored for safety and effectiveness after treatment

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ALXN2030

Trial Overview The study tests the effectiveness of ALXN2030 against a placebo in resolving biopsy-proven histologic signs of rejection by Week 52. It's a phase 2 trial, which means it focuses on the drug's efficacy and side effects.

How Is the Trial Designed?

Group I: ALXN2030 Dose B Experimental Treatment 1 Intervention

During the Double-Blind Treatment Period, participants will receive ALXN2030 dose B over 52 weeks. At Week 52, participants may continue into the OLE Period.

Group II: ALXN2030 Dose A Experimental Treatment 1 Intervention

During the Double-Blind Treatment Period, participants will receive ALXN2030 dose A over 52 weeks. At Week 52, participants may continue into the Open Label Extension (OLE).

Group III: Placebo Placebo Group 1 Intervention

Placebo will be administered during the Double-Blind Treatment Period of 52 weeks.

Who Is Running the Clinical Trial?

Alexion Pharmaceuticals, Inc.

Lead Sponsor

Trials

267

Recruited

141,000+

Dr. Alberto R. Martinez

Alexion Pharmaceuticals, Inc.

Chief Medical Officer since 2010

MD from University of Sao Paulo

Marc Dunoyer

Alexion Pharmaceuticals, Inc.

Chief Executive Officer since 2021

PhD in Molecular Biology

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06744647

NCT06744647 | Phase 2 Study of ALXN2030 in Patients ... This prospective trial will assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN2030 in kidney transplant recipients.

2. trialx.com trialx.com/clinical-trials/listings/325478/phase-2-study-of-alxn2030-in-patients-with-antibody-mediated-rejection-after-kidney-transplantation/

Phase 2 Study of ALXN2030 in Patients With Antibody- ... This prospective trial will assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN2030 in kidney transplant ...

3. uclahealth.org uclahealth.org/clinical-trials/phase-2-study-alxn2030-patients-with-antibody-mediated

Phase 2 Study of ALXN2030 in Patients With Antibody- ... The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants ...

4. withpower.com withpower.com/trial/phase-2-biopsy-proven-histologic-scores-2-2025-ed00a

ALXN2030 for Rejection After Kidney Transplant The research highlights the effectiveness of immunosuppressive drugs in reducing acute rejection rates in kidney transplants, with new agents like sirolimus and ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06744647/phase-2-study-of-alxn2030-in-patients-with-antibody-mediated-rejection-after-kidney-transplantation

Phase 2 Study of ALXN2030 in Patients With Antibody- ... This prospective trial will assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN2030 in kidney transplant ...

6. synapse.patsnap.com synapse.patsnap.com/drug/9dc3fdb8e407415e8440b3ed7141a1ea

ALXN-2030 - Drug Targets, Indications, Patents ... Safety of ALXN2030 in Adult Patients With Antibody-Mediated Rejection After Kidney Transplantation ... Clinical Results associated with ALXN-2030.