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NCT03221842 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
A Phase 3 study, sponsored by CSL Behring.
- Terminated
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
NCT03221842: Clinical Trial Phase 3 study, sponsored by CSL Behring.
NCT03221842 is a Phase 3 study that was terminated before completion, run by CSL Behring. The registered enrollment target is 63 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03221842, a Phase 3 study, was terminated before completion, sponsored by CSL Behring.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
Study Summary
This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
Primary Outcome
Loss of response is defined as 1 of the following, whichever occurs first: * Decline in Estimated Glomerular Filtration Rate (eGFR), or * Allograft failure, or * Subject death by any cause.
Interventions
- DRUG Placebo
- DRUG C1-esterase inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2017-11-06 |
| Est. Completion | 2021-01-20 |
| Phase | Phase 3 |
Why NCT03221842 stopped before completion
NCT03221842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03221842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03221842 about?
NCT03221842 is a clinical study titled "Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients". This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
What is the current status of trial NCT03221842?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2017-11-06. Estimated completion is 2021-01-20.
What interventions are being tested in trial NCT03221842?
The interventions under investigation include: Placebo (DRUG), C1-esterase inhibitor (DRUG).
Who is sponsoring clinical trial NCT03221842?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03221842's enrollment target sits among peer trials
63 1800th of 2000 higher than 199 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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