Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
Recruiting
Phase 2
Interventional Study
Antibody-Mediated Rejection
Kidney Transplantation
Biopsy-proven Histologic Scores
AMR
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 45 (estimated)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Contacts