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NCT03168906 · ClinicalTrials.gov registry record · Phase 2
Renal AL Amyloid Involvement and NEOD001
A Phase 2 study, sponsored by Tufts Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT03168906: Clinical Trial Phase 2 study, sponsored by Tufts Medical Center.
NCT03168906 is a Phase 2 study that was terminated before completion, run by Tufts Medical Center. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03168906, a Phase 2 study, was terminated before completion, sponsored by Tufts Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who have a maintained hematologic response to their most recent treatment for AL amyloidosis (e.g., chemotherapy, autologous stem cell transplant \[ASCT\]) and have persistent renal dysfunction.
Primary Outcome
A renal response is a ≥ 30% reduction in proteinuria in the absence of a ≥ 25% decrease in eGFR. A confirmed renal response is one that has been documented as present one month after 12 monthly treatments.
Interventions
- DRUG Placebo
- DRUG NEOD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2019-02-06 |
| Phase | Phase 2 |
Why NCT03168906 stopped before completion
NCT03168906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03168906 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03168906 about?
NCT03168906 is a clinical study titled "Renal AL Amyloid Involvement and NEOD001". This is a multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who have a maintained hematologic response to their most recent treatment for AL amyl...
What is the current status of trial NCT03168906?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2017-07-05. Estimated completion is 2019-02-06.
What interventions are being tested in trial NCT03168906?
The interventions under investigation include: Placebo (DRUG), NEOD001 (DRUG).
Who is sponsoring clinical trial NCT03168906?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03168906's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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