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NCT01221181 · ClinicalTrials.gov registry record · Phase 1
Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01221181 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 6 participants.
The verdict
NCT01221181, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This open label, non-blinded, proof of concept efficacy and safety study of eculizumab in patients with biopsy proven DDD or C3 nephropathy. The trial will consist of adult patients with these diseases who have \> 1 gram of proteinuria or a decreased glomerular filtration rate (GFR), both predictors of a poor long-term outcome in many glomerular diseases. The patients will be treated with eculizumab for one year. The goals will be to determine whether treatment leads to an improvement in kidney function, defined by remissions of proteinuria and improvements in estimated GFR (measured by serum creatinine), and to improvement in histologic parameters, including percentage of non-affected glomeruli, interstitial fibrosis, intensity of C3 staining of immunofluorescence, and amount of electron dense deposits by electron microscopy.
Interventions
- DRUG Eculizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01221181
The ClinicalTrials.gov registry entry for NCT01221181 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Eculizumab is the first listed.
NCT01221181 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01221181 about?
NCT01221181 is a clinical study titled "Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy". This open label, non-blinded, proof of concept efficacy and safety study of eculizumab in patients with biopsy proven DDD or C3 nephropathy. The trial will consist of adult patients with these diseases who have \> 1 gram of proteinuria or a decreased glomerular filtration rate (GFR), both predictors...
What is the current status of trial NCT01221181?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2010-07. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01221181?
The interventions under investigation include: Eculizumab (DRUG).
Who is sponsoring clinical trial NCT01221181?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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