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NCT01147302 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01147302: Completed Phase 2 study, sponsored by Shire.
NCT01147302 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01147302, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
Primary Outcome
The protocol-specified Day 20 (post-treatment) biopsy was compared to the qualifying biopsy to assess changes in histopathology for light and immunofluorescence microscopy. The Central Pathologist provided the following categorical information from the qualifying biopsy in an AMR Scorecard: C4d Score (0-100), Margination Score (0-100) Glomerulitis Score (0-100), Vasculitis Score (0-100), Glomerulosclerosis Score (0-100), Chronic Glomerulopathy Score (0-100), Interstitial Fibrosis Score (0-100),
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL C1 Esterase Inhibitor (Human)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-08-24 |
| Est. Completion | 2013-06-28 |
| Phase | Phase 2 |
What the finished NCT01147302 record still lists
NCT01147302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01147302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01147302 about?
NCT01147302 is a clinical study titled "A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection". The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
What is the current status of trial NCT01147302?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2011-08-24. Estimated completion is 2013-06-28.
What interventions are being tested in trial NCT01147302?
The interventions under investigation include: Placebo (BIOLOGICAL), C1 Esterase Inhibitor (Human) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01147302?
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 NCT01147302's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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