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Efficacy and Safety in Chinese Patients with Immunoglobulin a Nephropathy (IgAN) Who Have Completed Study Nef-301

NCT05534919 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-11-12

No results posted yet for this study

Summary

This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients who have completed Nef-301 and continue to be treated with a stable dose of Renin-angiotensin system (RAS) inhibitor therapy (Angiotensin-converting enzyme inhibitors (ACEIs) and/or Angiotensin II type I receptor blockers (ARBs).

Conditions

  • Primary Immunoglobulin a Nephropathy (IgAN)

Interventions

DRUG

Nefecon

Nefecon is taken orally as capsules once daily for 9 months.

Sponsors & Collaborators

  • Everest Medicines (Singapore) Pte. Ltd.

    lead OTHER

Principal Investigators

  • Jicheng Lv, Doctor · Peking University First Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-09
Primary Completion
2024-07-17
Completion
2024-07-17

Countries

  • China

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 NCT05534919 on ClinicalTrials.gov