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NCT02547220 · ClinicalTrials.gov registry record · Phase 3
A Multicenter Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Participants With Kidney Transplant
A Phase 3 study, sponsored by Shire.
- Terminated
- Registry status
- Phase 3
- Development phase
- 39
- Enrollment target
NCT02547220: Clinical Trial Phase 3 study, sponsored by Shire.
NCT02547220 is a Phase 3 study that was terminated before completion, run by Shire. The registered enrollment target is 39 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02547220, a Phase 3 study, was terminated before completion, sponsored by Shire.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 39 participants
- Enrollment target
Study Summary
The main purpose of the study is to evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft in kidney transplant recipients as measured by the proportion of participants with new or worsening transplant glomerulopathy (TG) at 6 months after treatment initiation.
Primary Outcome
New or worsening TG at month 6 by the standard score was defined as an increase in one or more between qualifying biopsy and 6-month biopsy. New or worsening TG was measured by Banff 2013 criteria (standard score) using allograft glomerulopathy (Cg0-Cg3): Cg0- No GBM double contours by light microscopy (LM) or electron microscopy (EM); Cg1- no GBM double contours by LM but GBM double contours in at least 3 glomerular capillaries by EM; Cg2- Double contours affecting 26 to 50% of peripheral capil
Interventions
- DRUG Placebo
- BIOLOGICAL Cinryze®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2016-05-20 |
| Est. Completion | 2019-05-31 |
| Phase | Phase 3 |
Why NCT02547220 stopped before completion
NCT02547220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02547220 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02547220 about?
NCT02547220 is a clinical study titled "A Multicenter Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Participants With Kidney Transplant". The main purpose of the study is to evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft in kidney transplant recipien...
What is the current status of trial NCT02547220?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2016-05-20. Estimated completion is 2019-05-31.
What interventions are being tested in trial NCT02547220?
The interventions under investigation include: Placebo (DRUG), Cinryze® (BIOLOGICAL).
Who is sponsoring clinical trial NCT02547220?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02547220's enrollment target sits among peer trials
39 1898th of 2000 higher than 101 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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