ALXN2030 for Rejection After Kidney Transplant

(CONCORD Trial)

Recruiting at 41 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

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.

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.

What data supports the effectiveness of the drug 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 everolimus showing promise in improving long-term outcomes. While ALXN2030 is not specifically mentioned, the success of similar immunosuppressive drugs suggests potential effectiveness in managing rejection after kidney transplants. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Renal transplantation: basic concepts and evolution of therapy. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Acute rejection episodes after renal transplantation in children. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Progress in the clinical application of immunosuppressive drugs in renal transplantation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The incidence and impact of early rejection episodes on graft outcome in recipients of first cadaver kidney transplants. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Chronic allograft nephropathy. [2006]