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RECRUITING
NCT04614558
PHASE2

Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

Sponsor: Columbia University

View on ClinicalTrials.gov

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'.

Official title: A Single Arm, Multicenter, Phase II, Open-Label Trial to Evaluate Efficacy of Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2021-06-08

Completion Date

2026-06

Last Updated

2025-06-06

Healthy Volunteers

No

Interventions

DRUG

Isatuximab

Isatuximab in IV form (10mg/kg q weekly x 4 doses followed by 10mg/kg q 2 weeks) for a total of 6 month duration. Doses should be initiated at 175 mg/hour up to a maximum of 400 mg/hour. Isatuximab (SAR) is monoclonal antibody (mAb).

Locations (2)

Massachusetts General Hospital, Renal Associates Clinic

Boston, Massachusetts, United States

Columbia University Irving Medical Center

New York, New York, United States