Actively Recruiting
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate ALXN2030 in Adults With Antibody-Mediated Rejection After Kidney Transplantation
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-27
45
Participants Needed
55
Research Sites
56 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effects of ALXN2030 in adult kidney transplant recipients who have active or chronic active antibody-mediated rejection (AMR). This phase 2, randomized, double-blind trial aims to compare ALXN2030 with a placebo to see how well it resolves AMR as confirmed by biopsy at Week 52. The study also assesses safety, how the drug moves through and acts in the body, and immune response to the drug. Participants will be randomly assigned to one of three groups: ALXN2030 Dose A, ALXN2030 Dose B, or placebo. All groups receive standard immunosuppressive therapy alongside study treatments. The treatments are given subcutaneously over a 52-week double-blind period. After this, those who received placebo will be re-randomized to receive ALXN2030 either at Dose A or Dose B during a 52-week open-label extension. Following treatment, participants enter a safety follow-up period lasting 48 weeks after the last dose. Throughout the study, participants will undergo kidney biopsies at Weeks 28 and 52 to evaluate the rejection status. Researchers will also monitor kidney function, drug levels in the blood, immune markers, and any adverse events from Day 1 up to Week 104. The total participation time includes treatment, extension, and follow-up phases, allowing comprehensive assessment of ALXN2030 effects and safety in kidney transplant patients with AMR.
CONDITIONS
Brief Title
Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Kidney transplant received at least 6 months prior
- Active or chronic active antibody-mediated rejection based on biopsy and Banff 2022 classification
- Positive C4d on biopsy and/or positive HLA Class I/II antigen-specific donor-specific antibodies
- Microvascular inflammation score of at least 2 (g ≥ 1 and ptc ≥ 1)
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2
- Vaccinated against meningococcal infection (serogroups A, C, W, Y, and B where available) between 14 days and 3 years before Day 1
- Vaccinated against Streptococcus pneumoniae prior to randomization
- Vaccinated against Haemophilus influenzae type B prior to randomization
- Body weight of at least 50 kg at screening
You will not qualify if you...
- Diagnosis at screening of T-cell mediated rejection (Banff grade ≥ 1), polyoma virus nephropathy, severe thrombotic microangiopathy, or glomerulonephritis
- ABO-incompatible transplant
- Urine albumin-to-creatinine ratio greater than 2200 mg/g
- Recipient of multiorgan transplant (except multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell)
- Recent or planned treatments within 90 days before screening for acute rejection or antibody-mediated rejection, excluding stable standard immunosuppressants
- Known medical or psychological conditions, including substance abuse or risk factors, that may interfere with participation or increase risk or confound outcomes
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants receive ALXN2030 or placebo subcutaneously along with standard immunosuppressive treatment during a double-blind period.
Repeated allograft biopsy visits at 28 and 52 weeks
Duration - 52 weeks
Participants who complete the double-blind treatment may continue receiving ALXN2030 during the open-label extension period.
Duration - 48 weeks after last dose
Participants are monitored for safety after completing treatment.
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
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
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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