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ARTEMIS - IGAN

Title A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)
Therapeutic Area Nephropathy
Principal Investigator Lesley Inker, MD, MS
Min Age 18 Years
Gender Any
Contact Victoria J Wang
617-636-9423
vwang3@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03608033

Overview

ARTEMIS – IGaN is a maximum 160 week a Phase 3 trial evaluating the Safety and Efficacy of OMS721 in patients with Immunoglobulin A (IgA) Nephropathy

Study Details

Inclusion Criteria

  • Biopsy confirmed diagnosis of IgAN (may be provided)

Exclusion Criteria

  • Kidney or any other soild organ transplant recipient or planned transplat during the study
  • Body mass index ≥ 35 kg/m²

Study Requirements

The study consists of five periods: Screening, Run-In, Initial Treatment (Weeks 1-12)
Response Evaluation (Weeks 13-24)
Follow-Up (Weeks 25 to end-of-study)
The study duration for each patient is expected to last up to 160 weeks.