Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06744647

Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation

Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-27

45

Participants Needed

55

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Kidney transplant received 63 6 months
  • Active or chronic active AMR according to Banff 2022 classification based on screening kidney biopsy
  • Positive C4d on screening biopsy and/or positive HLA Class I or II antigen-specific DSA
  • MVI score 63 2 (g 63 1 and ptc 63 1)
  • eGFR 63 30 mL/min/1.73 m2
  • Vaccinated against meningococcal infection at least 14 days and no more than 3 years prior to Day 1
  • Vaccinated for Streptococcus pneumoniae prior to randomization
  • Vaccinated for Haemophilus influenzae type B prior to randomization
  • Body weight 63 50 kg at screening
Not Eligible

You will not qualify if you...

  • Biopsy diagnosis at screening of TCMR grade 63 1
  • Polyoma virus nephropathy
  • Severe thrombotic microangiopathy
  • Glomerulonephritis
  • ABO-incompatible transplant
  • Urine albumin-to-creatinine ratio (uACR) > 2200 mg/g
  • Multiorgan or cell transplant recipient (except previous multiple kidney transplants)
  • Recent or planned treatments within 90 days for acute rejection or AMR (except stable standard immunosuppressants)
  • Known medical or psychological condition, including substance abuse, that may interfere with study or increase risk

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 55 locations

1

Research Site

Birmingham, Alabama, United States, 35249

Actively Recruiting

2

Research Site

Scottsdale, Arizona, United States, 85259

Actively Recruiting

3

Research Site

Los Angeles, California, United States, 90095

Actively Recruiting

4

Research Site

Orange, California, United States, 92868

Actively Recruiting

5

Research Site

Tampa, Florida, United States, 33606

Actively Recruiting

6

Research Site

Atlanta, Georgia, United States, 30309

Actively Recruiting

7

Research Site

Kansas City, Kansas, United States, 66160

Actively Recruiting

8

Research Site

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

9

Research Site

Detroit, Michigan, United States, 48202

Actively Recruiting

10

Research Site

Livingston, New Jersey, United States, 07039

Actively Recruiting

11

Research Site

New York, New York, United States, 10016

Withdrawn

12

Research Site

New York, New York, United States, 10021

Actively Recruiting

13

Research Site

New York, New York, United States, 10029

Actively Recruiting

14

Research Site

New York, New York, United States, 10032

Actively Recruiting

15

Research Site

Durham, North Carolina, United States, 27705

Actively Recruiting

16

Research Site

Cincinnati, Ohio, United States, 45267

Not Yet Recruiting

17

Research Site

Philadelphia, Pennsylvania, United States, 19140

Not Yet Recruiting

18

Research Site

Charleston, South Carolina, United States, 29425

Withdrawn

19

Research Site

Dallas, Texas, United States, 75235

Actively Recruiting

20

Research Site

Houston, Texas, United States, 77030

Actively Recruiting

21

Research Site

Richmond, Virginia, United States, 23298

Actively Recruiting

22

Research Site

Seattle, Washington, United States, 98195

Actively Recruiting

23

Research Site

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

24

Research Site

Botucatu, Brazil, 18618-687

Actively Recruiting

25

Research Site

Campinas, Brazil, 13083

Actively Recruiting

26

Research Site

Porto Alegre, Brazil, 90020-090

Actively Recruiting

27

Research Site

São Paulo, Brazil, 04038-002

Actively Recruiting

28

Research Site

São Paulo, Brazil, 05403-900

Actively Recruiting

29

Research Site

Calgary, Alberta, Canada, T2N 1N4

Not Yet Recruiting

30

Research Site

Edmonton, Alberta, Canada, T6G 2R7

Actively Recruiting

31

Research Site

Vancouver, British Columbia, Canada, V6Z 1Y6

Actively Recruiting

32

Research Site

London, Ontario, Canada, N6A 5A5

Actively Recruiting

33

Research Site

Toronto, Ontario, Canada, M5G 2N2

Not Yet Recruiting

34

Research Site

Montreal, Quebec, Canada, H4A 3J1

Withdrawn

35

Research Site

Changsha, China, 430033

Actively Recruiting

36

Research Site

Guangzhou, China, 510080

Actively Recruiting

37

Research Site

Nanning, China, 530007

Actively Recruiting

38

Research Site

Shanghai, China, 201114

Actively Recruiting

39

Research Site

Wuhan, China, 430030

Actively Recruiting

40

Research Site

Xi'an, China, 710061

Actively Recruiting

41

Research Site

Seoul, South Korea, 02841

Actively Recruiting

42

Research Site

Seoul, South Korea, 03080

Actively Recruiting

43

Research Site

Seoul, South Korea, 06351

Actively Recruiting

44

Research Site

Seoul, South Korea, 06591

Actively Recruiting

45

Research Site

Seoul, South Korea, 3722

Actively Recruiting

46

Research Site

Barcelona, Spain, 08035

Actively Recruiting

47

Research Site

Barcelona, Spain, 8003

Actively Recruiting

48

Research Site

Zaragoza, Spain, 50009

Actively Recruiting

49

Research Site

Kaohsiung City, Taiwan, 813

Actively Recruiting

50

Research Site

Kaohsiung City, Taiwan, 833401

Actively Recruiting

51

Research Site

Taichung, Taiwan, 40705

Actively Recruiting

52

Research Site

Taoyuan, Taiwan, 333

Withdrawn

53

Research Site

Birmingham, United Kingdom, B15 2GW

Actively Recruiting

54

Research Site

London, United Kingdom, NW3 2QG

Actively Recruiting

55

Research Site

London, United Kingdom, W12 0HS

Actively Recruiting

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Research Team

A

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation | DecenTrialz