Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

July 31, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Glomerulonephritis, IGAProbioticsBudesonide
Interventions
DRUG

probiotics combined with enteric-coated budesonide capsule

"In the 9-month treatment period, the following treatments will be received: probiotics combined with enteric-coated budesonide capsules group: 1 bag/day of probiotics (each bag added active probiotic Lactobacillus casei Zhang ≥100 billion CFU) +16 mg/day oral enteric-coated budesonide capsules.~After completing the treatment period, participants will enter a 2-week reduction period to reduce the risk of adrenal insufficiency. ① enteric-coated budesonide capsules reduction: 8 mg/day oral enteric-coated budesonide capsules."

DRUG

probiotics placebo combined with enteric-coated budesonide capsules

"In the 9-month treatment period, the following treatments will be received: probiotics placebo combined with enteric-coated budesonide capsules group: 1 bag/day of probiotics placebo +16 mg/day oral enteric-coated budesonide capsules.~After completing the treatment period, participants will enter a 2-week reduction period to reduce the risk of adrenal insufficiency. ① enteric-coated budesonide capsules reduction: 8 mg/day oral enteric-coated budesonide capsules."

Trial Locations (1)

Unknown

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan

All Listed Sponsors
collaborator

China Primary Health Care Foundation

UNKNOWN

lead

Gang Xu

OTHER

NCT06528015 - Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy | Biotech Hunter | Biotech Hunter