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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: Completed Phase 1 study, sponsored by Columbia University.
NCT01221181 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This is designed to measure response to eculizumab through clinical and histological data, including a reduction in serum creatinine or in proteinuria, or histopathologic improvement. Any reduction in serum creatinine and/or proteinuria was included in our descriptive analysis.
Interventions
- DRUG Eculizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
What the finished NCT01221181 record still lists
NCT01221181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Eculizumab is the first listed.
NCT01221181 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01221181's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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