MedTrace Logo

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

NCT03643965 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2024-12-03

Study results available
· View outcomes & findings →

Summary

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Conditions

Interventions

DRUG

Nefecon

Nefecon 16 mg for daily administration by mouth for 9 months.

DRUG

Placebo oral capsule

Placebo capsules for daily administration by mouth for 9 months.

Sponsors & Collaborators

  • Calliditas Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Krassimir Mitchev, MD · Calliditas AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2023-07-10
Completion
2023-07-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belarus
  • Belgium
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • 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 NCT03643965 on ClinicalTrials.gov