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Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)

NCT04541043 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2025-02-10

Study results available
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Summary

This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef-301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon.

Conditions

Interventions

DRUG

Nefecon 16mg daily

All study patients received Nefecon 16 mg daily for 9 months.

Sponsors & Collaborators

  • Calliditas Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Richard Philipson, MD · Calliditas Therapeutics AB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2024-02-26
Completion
2024-02-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belarus
  • Belgium
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04541043 on ClinicalTrials.gov