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Renal AL Amyloid Involvement and NEOD001

NCT03168906 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-09-09

Study results available
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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.

Conditions

  • Amyloidosis

Interventions

DRUG

NEOD001

NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates

DRUG

Placebo

Saline bag

Sponsors & Collaborators

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Raymond Comenzo, MD · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2018-04-23
Completion
2019-02-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03168906 on ClinicalTrials.gov