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

NCT06589752 | Completed FDA Drug

• 1 other identifier: RepIgAN
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary IgA Nephropathy

Outcome Measures

Primary Outcomes (2)

• Change in Urinary Protein Levels from Baseline at 9 months Primary endpoint

  Assessment of the change in 24-hour urine protein levels from baseline after 9 months of follow-up.

  9 months

• Change in eGFR from Baseline at 9 Months

  Measurement of the change in estimated glomerular filtration rate (eGFR) from baseline after 9 months of follow-up.

  9 months

Secondary Outcomes (3)

• Change in 24-Hour Urine Protein Levels Compared to Baseline at 12 Months

  12 months

• Change in eGFR Compared to Baseline at 12 Months

  12 months

• Incidence Rate of Adverse Events

  12 months

Study Arms (2)

Treat

TRF-budesonide enteric-coated capsule（TARPEYO）

Drug: TARPEYO 4 MG Delayed Release Oral Capsule

Control

RAS blocker

Drug: RAS inhibitor

Interventions

TARPEYO 4 MG Delayed Release Oral Capsule DRUG

TARPEYO dispensing claim for any dose is exposure

Treat

RAS inhibitor DRUG

RASi dispensing claim for any dose is reference

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary IgA nephropathy

You may qualify if:

• Male or female patients aged ≥18 years;
• Primary IgA nephropathy confirmed by renal biopsy;
• Stable use of RAS blockers;
• hour urine albumin quantitation ≥1g/day, or urine protein/creatinine ratio ≥0.8g/g (≥90 mg/mmol);
• eGFR ≥30 mL/min/1.73m².

You may not qualify if:

• Systemic diseases that may cause interstitial IgA deposition, including but not limited to anaphylactoid purpura, systemic lupus erythematosus, herpetic dermatitis, and ankylosing spondylitis;
• Patients who have received kidney transplants;
• Those with other glomerular diseases (such as C3 glomerular disease or diabetic nephropathy) and nephrotic syndrome;
• Patients with acute, chronic, or latent infectious diseases, including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections;
• Patients with cirrhosis or severe liver function impairment, as assessed by the investigator;
• Patients diagnosed with poorly controlled type 1 or type 2 diabetes;
• Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or arrhythmia as assessed by the investigator;
• Patients with poorly controlled blood pressure with systolic or diastolic blood pressure ≥140mmHg or 90mmHg. At least one blood pressure measurement should be in the above range (based on up to three measurements, 1 minute apart, taken after resting in the supine position for at least 5 minutes);
• Patients diagnosed with malignancy within the last 5 years, with the exception of treated basal cell carcinoma of the skin, curably resected squamous cell carcinoma of the skin, polyps of the colon, or carcinoma in situ of the cervix;
• Patients with osteoporosis who are known to be at moderate or high risk. Chinese patients are defined according to the Asian Osteoporosis Self-Assessment Tool (OSTA) Index;
• Patients with known glaucoma, known history of cataract and/or cataract surgery that may interfere with study drug action or release (such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea);
• Patients who are allergic to budesonide or any component of the investigational drug formulation;
• Patients who have previously had a severe adverse reaction to steroids;
• Patients with psychotic symptoms;
• Have received any systemic glucocorticoid therapy within 3 months prior to medication;

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: September 19, 2024
• Study Start: April 24, 2023
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)