Antibody-Mediated RejectionPhase 2CONCORDNCT06744647
Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
A Phase 2 study testing ALXN2030 in people with Antibody-Mediated Rejection and Kidney Transplantation, run by Alexion Pharmaceuticals, Inc. at 51 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Antibody-Mediated Rejection, Kidney Transplantation, Biopsy-proven Histologic Scores
- What is being tested?
- ALXN2030
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 51 sitesin 8 countries
- Study dates
- 7 Mar 2025to 7 Nov 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant received ≥ 6 months
- Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy
- Either positive C4d on Screening kidney biopsy based on the Central Pathology Laboratory report and/or positive HLA Class I and/or II antigen-specific DSA as determined by the local laboratory's definition of positivity using single-antigen bead based assays
- MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)
- eGFR ≥ 30 mL/min/1.73 m2
- Must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) at least 14 days prior to but no more than 3 years prior to Day 1
Show all 9Show fewer
- Must be vaccinated for S pneumoniae prior to randomization
- Must be vaccinated for H influenzae type B (where available) prior to randomization
- Body weight ≥ 50 kg at Screening
Who cannot join
- Biopsy-based diagnosis of any of the following at Screening:
- TCMR, according to the Banff grade ≥ 1
- Polyoma virus nephropathy
- Severe thrombotic microangiopathy
- Glomerulonephritis
- ABO-incompatible transplant
Show all 10Show fewer
- uACR > 2200 mg/g
- Multiorgan transplant recipient (except for previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient
- Planned or recent treatments, < 90 days prior to the Screening Visit and during Screening, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids [except for tapering]), HDS products with known hepatotoxic ingredients, TCMR (including T-cell depleting therapy), excluding the SoC immunosuppressant treatment which will be allowed and should be stable during the entire treatment.
- Known medical or psychological condition, including substance abuse or use disorder (including alcohol), or risk factor that may interfere with study participation, pose additional risk, or confound study outcomes
Trial locations and contacts
51 sites in 8 countries.
51 sites in 8 countries
United States21 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Atlanta, Georgia, 30309
Research Site
Birmingham, Alabama, 35249
Research Site
Cincinnati, Ohio, 45267
Research Site
Dallas, Texas, 75235
Research Site
Detroit, Michigan, 48202
Research Site
Durham, North Carolina, 27705
Research Site
Houston, Texas, 77030
Research Site
Kansas City, Kansas, 66160
Research Site
Livingston, New Jersey, 07039
Research Site
Los Angeles, California, 90095
Research Site
Milwaukee, Wisconsin, 53226
Research Site
New York, New York, 10021
Research Site
New York, New York, 10029
Research Site
New York, New York, 10032
Research Site
Orange, California, 92868
Research Site
Philadelphia, Pennsylvania, 19140
Research Site
Richmond, Virginia, 23298
Research Site
Scottsdale, Arizona, 85259
Research Site
Seattle, Washington, 98195
Research Site
Tampa, Florida, 33606
China6 sites
Research Site
Changsha, 430033
Research Site
Guangzhou, 510080
Research Site
Nanning, 530007
Research Site
Shanghai, 201114
Research Site
Wuhan, 430030
Research Site
Xi'an, 710061
Brazil5 sites
Research Site
Botucatu, 18618-687
Research Site
Campinas, 13083
Research Site
Porto Alegre, 90020-090
Research Site
São Paulo, 04038-002
Research Site
São Paulo, 05403-900
Canada5 sites
Research Site
Calgary, Alberta, T2N 1N4
Research Site
Edmonton, Alberta, T6G 2R7
Research Site
London, Ontario, N6A 5A5
Research Site
Toronto, Ontario, M5G 2N2
Research Site
Vancouver, British Columbia, V6Z 1Y6
South Korea5 sites
Research Site
Seoul, 02841
Research Site
Seoul, 03080
Research Site
Seoul, 06351
Research Site
Seoul, 06591
Research Site
Seoul, 3722
Spain3 sites
Research Site
Barcelona, 08035
Research Site
Barcelona, 8003
Research Site
Zaragoza, 50009
Taiwan3 sites
Research Site
Kaohsiung City, 813
Research Site
Kaohsiung City, 833401
Research Site
Taichung, 40705
United Kingdom3 sites
Research Site
Birmingham, B15 2GW
Research Site
London, NW3 2QG
Research Site
London, W12 0HS
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN2030 in Adult Patients With Antibody-Mediated Rejection After Kidney Transplantation
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.
Read the detailed description
This prospective trial will assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN2030 in kidney transplant recipients with active or chronic active AMR. The study is designed as a randomized, controlled, double-blind phase 2 trial. Participants will be randomized in a 1:1:1 ratio to receive either ALXN2030 Dose A, ALXN2030 Dose B, or placebo for a double-blind treatment period of 52 weeks. All arms will receive standard of care immunosuppressive treatment. During the treatment period, study participants will be subjected to repeated allograft biopsies at 28 and 52 weeks. At the end of the double-blind treatment period, participants may continue into the Open-Label Extension (OLE) Treatment Period (52 weeks). Participants randomized to placebo will be re-randomized 1:1 to ALXN2030 Dose A or ALXN2030 Dose B. Safety Follow-Up will start after the end of Treatment (Week 104) until week 48 after the last dose.
- Being tested
- ALXN2030, Placebo
- Keywords
- ALXN2030, Antibody-Mediated Rejection, Kidney Transplantation, Biopsy-proven histologic scores, AMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN2030Drug
ALXN2030 will be administered subcutaneously (SC).
PlaceboDrug
Placebo will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo will be administered during the Double-Blind Treatment Period of 52 weeks. Receives: Drug: Placebo |
| ALXN2030 Dose A | Experimental | 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). Receives: Drug: ALXN2030 |
| ALXN2030 Dose B | Experimental | 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. Receives: Drug: ALXN2030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy-proven histologic resolution
Measured: Week 52
Secondary outcomes (10)
Biopsy-proven histologic resolution
Measured: Week 28
Change From Baseline in biopsy-proven histologic scores
Measured: Baseline, Weeks 28 and 52
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Measured: Baseline up to week 52
Annualized Total eGFR Slope
Measured: Baseline up to Week 52
Stabilized eGFR
Measured: Baseline up to Week 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs)
Measured: Day 1 up to Week 104
Number of Participants With Anti-drug Antibodies (ADAs)
Measured: Day 1 through Week 104
Plasma Concentration of ALXN2030
Measured: Baseline up to Week 104
Plasma Concentration of C3 Protein
Measured: Baseline up to Week 104
Change From Baseline in Serum Complement Functional Activity
Measured: Baseline, up to Week 52 and up to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start7 Mar 2025
- Primary completion11 Oct 2027 (estimated)
- Study completion7 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibody-Mediated RejectionStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744647
- Sponsor's protocol ID
- D8560C00002
- Acronym
- CONCORD
- Status last verified
- Aug 2026
- First submitted
- 13 Dec 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Publications
Beltran J, Bolton S, Patel P, Sharma R. Patient engagement in protocol development for rare disease clinical trials: a framework. Res Involv Engagem. 2026 Oct 9;12(1):167. doi: 10.1186/s40900-026-00985-3.
PubMed 42855714