NCT06589752

Replication of the NefIgArd Trial of TRF-budesonide in Primary IgAN

Replication of the NefIgArd Trial of Effectiveness and Safety of a Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This replication of the NefIgArd trial of TRF-budesonide aims to use real-world data to evaluate the efficiency and safety of TRF-budesonide in the treatment of IgA nephropathy, from completing real-world research to providing real-world evidence.

Detailed description

Currently, TRF-budesonide are the first specific treatment for IgA nephropathy that targets intestinal mucosal immunity. Results from part A of the Phase III clinical trial (NCT03643965) show that compared to the placebo group, the TRF-budesonide group significantly reduced proteinuria and hematuria, stabilized renal function, and lowered circulating Gd-IgA1 levels at 12 months. However, further real-world studies are needed to verify the efficiency and safety of this treatment for IgA nephropathy. Therefore, this replication trial of the part A of the Phase III clinical trial NefIgArd and evaluates the efficiency and safety of TRF-budesonide in treating IgA nephropathy based on existing observational data, aiming to complete real-world research to provide real-world evidence that can guide clinical practice for IgA nephropathy treatment.

Conditions

• Primary IgA Nephropathy

Interventions

Type	Name	Description
DRUG	TARPEYO 4 MG Delayed Release Oral Capsule	TARPEYO dispensing claim for any dose is exposure
DRUG	RAS inhibitor	RASi dispensing claim for any dose is reference

Timeline

• Start date: 2023-04-24
• Primary completion: 2024-09-05
• Completion: 2024-09-05
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study