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FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS)

NCT03422510 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-08-03

No results posted yet for this study

Summary

This is a multicenter, open label, randomized study investigating two dose titration regimens of CXA-10 in subjects at least 18 years of age with primary FSGS.

The study will be performed at approximately 25 study centers across the United States of America (USA). The recruitment period is anticipated to be up to approximately 16 months. Approximately 30 subjects will be randomized to ensure 26 subjects complete the study. An optional 9 month open label is available

Conditions

  • Primary Focal Segmental Glomerulosclerosis

Interventions

DRUG

CXA-10

CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)

Sponsors & Collaborators

  • Kidney Research Network, formerly NephCure Accelerating Cures Institute

    collaborator UNKNOWN

  • Medpace, Inc.

    collaborator INDUSTRY

  • MicroConstants

    collaborator UNKNOWN

  • Arkana Labs

    collaborator UNKNOWN

  • NephCure Kidney International

    collaborator UNKNOWN

  • Complexa, Inc.

    lead INDUSTRY

Principal Investigators

  • Theodore Danoff, MD · Complexa, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03422510 on ClinicalTrials.gov