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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 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.

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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'.

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

FieldValue
Enrollment Target 27 participants
Start Date 2021-06-08
Est. Completion 2026-06
Phase Phase 2

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT04614558

The ClinicalTrials.gov registry entry for NCT04614558 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 131-participant average among 3 other Monoclonal Gammopathy trials with a reported enrollment target (79% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.