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NCT04614558 · ClinicalTrials.gov registry record · Phase 2
Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance
A Phase 2 study of Monoclonal Gammopathy, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 2
- Study locations
NCT04614558: Recruiting Phase 2 study of Monoclonal Gammopathy, sponsored by Columbia University.
NCT04614558 is a Phase 2 study of Monoclonal Gammopathy that is actively recruiting participants, run by Columbia University. The registered enrollment target is 27 participants, below the 131-participant average among 3 other Monoclonal Gammopathy trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04614558, a Phase 2 study of Monoclonal Gammopathy, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to see whether Isatuximab can help improve kidney function of participants with MGRS. Isatuximab is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma, but it is not approved by the FDA to treat MGRS. This means that the use of isatuximab in this study is considered 'investigational'.
Primary Outcome
Renal response defined as a decrease in 24-hour proteinuria by \>50% at any point post therapy.
Conditions Studied
Interventions
- DRUG Isatuximab
Study Locations (2)
Massachusetts
- Massachusetts General Hospital, Renal Associates Clinic - Boston
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2021-06-08 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT04614558 shows while recruiting
NCT04614558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 131-participant average among 3 other Monoclonal Gammopathy trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Monoclonal Gammopathy appearing as the primary indexed condition, and to 1 intervention - of which Isatuximab is the first listed.
NCT04614558 reports a single indexed study location in Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT04614558 about?
NCT04614558 is a clinical study titled "Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance". The purpose of this study is to see whether Isatuximab can help improve kidney function of participants with MGRS. Isatuximab is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma, but it is not approved by the FDA to treat MGRS. This means t...
What is the current status of trial NCT04614558?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2021-06-08. Estimated completion is 2026-06.
What conditions does trial NCT04614558 study?
This clinical trial studies the following conditions: Monoclonal Gammopathy.
What interventions are being tested in trial NCT04614558?
The interventions under investigation include: Isatuximab (DRUG).
Who is sponsoring clinical trial NCT04614558?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04614558 being conducted?
This trial has 2 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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