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

ConditionsAntibody-Mediated RejectionKidney TransplantationBiopsy-proven Histologic ScoresAMR
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAlexion Pharmaceuticals, Inc.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

TCMR, according to the Banff grade ≥ 1

Polyoma virus nephropathy

Severe thrombotic microangiopathy

Glomerulonephritis

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALXN2030

    Drug

    ALXN2030 will be administered subcutaneously (SC).

  • Placebo

    Drug

    Placebo will be administered SC.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: ALXN2030 Dose AExperimental treatment 1 intervention
Group C: ALXN2030 Dose BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Biopsy-proven histologic resolution

Time frame
Week 52

Secondary outcomes

1

Biopsy-proven histologic resolution

Time frame
Week 28
2

Change From Baseline in biopsy-proven histologic scores

Time frame
Baseline, Weeks 28 and 52
3

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52

Time frame
Baseline up to week 52
4

Annualized Total eGFR Slope

Time frame
Baseline up to Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexion Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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