Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528015
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy a Prospective Multicenter Randomized Single-blind Placebo-controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy and safety of probiotics combined with enteric-coated budesonide capsule in patients with IgA nephropathy on the basis of optimized RAS blockade therapy and to explore the correlation between the efficacy of probiotics combined with enteric-coated budesonide capsule in the treatment of primary IgA nephropathy and intestinal homeostasis
The main questions it aims to answer are
Dose probiotics combined with enteric-coated budesonide capsule provide a durable reduction in urine protein creatinine ratio UPCR in participants compared with probiotics placebo combined with enteric-coated budesonide capsule What medical problems do participants have when taking probiotics combined with enteric-coated budesonide capsule
Participants will
Take probiotics combined with enteric-coated budesonide capsules or probiotics placebo combined with enteric-coated budesonide capsules every day for 95 month Participate in center site follow-up visits for 13 times Keep a diary of their symptoms and outcomes
The main questions it aims to answer are
Dose probiotics combined with enteric-coated budesonide capsule provide a durable reduction in urine protein creatinine ratio UPCR in participants compared with probiotics placebo combined with enteric-coated budesonide capsule What medical problems do participants have when taking probiotics combined with enteric-coated budesonide capsule
Participants will
Take probiotics combined with enteric-coated budesonide capsules or probiotics placebo combined with enteric-coated budesonide capsules every day for 95 month Participate in center site follow-up visits for 13 times Keep a diary of their symptoms and outcomes
Detailed Description:
This is a prospective multicenter randomized single-blind placebo-controlled clinical trial The study included a screening period 7-15 days an induction period at least 3 months randomization a treatment period 9 months a reduction period 2 weeks a safety follow-up period 25 months and a long-term follow-up period 36 months Participants who meet the randomization criteria will be randomly assigned 11 to receive probiotics combined with enteric-coated budesonide capsules or probiotics placebo combined with enteric-coated budesonide capsules
Screening period 7-15 days Participants who sign the informed consent for this study and undergo relevant examinations can enter the induction period if they meet the screening criteria
Induction period at least 3 months Optimized treatment with RAS blockers is performed immediately upon entry the induction period
Randomization RAS blockers were used for at least 3 months during the induction period All inclusion conditions had to be met to qualify for randomization
Treatment period 9 months Participants who meet the randomization criteria will be randomly assigned 11 to receive probiotics combined with enteric-coated budesonide capsules group or probiotics placebo combined with enteric-coated budesonide capsules In the 9-month treatment period the following treatments will be received ① probiotics combined with enteric-coated budesonide capsules group 1 bagday of probiotics each bag added active probiotic Lactobacillus casei Zhang 100 billion CFU 16 mgday oral enteric-coated budesonide capsules ② probiotics placebo combined with enteric-coated budesonide capsules group 1 bagday of probiotics placebo 16 mgday oral enteric-coated budesonide capsules
The RAS blocker ACEI or ARB dosing regimen needs to be stable during treatment period
Reduction period 2 weeks 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 mgday oral enteric-coated budesonide capsules
The RAS blocker ACEI or ARB dosing regimen needs to be stable during reduction period
Safety follow-up period 25 months After completion of the reduction period all participants stopped taking the investigational drug completed the remainder of the safety follow-up period During this time the RAS blocker ACEI or ARB dosing regimen needs to be stable
Long-term follow-up period 36 months Participants who have completed the treatment period reduction period and safety follow-up period as well as those who terminated the study treatment early but did not withdraw from the study will enter long-term follow-up
Screening period 7-15 days Participants who sign the informed consent for this study and undergo relevant examinations can enter the induction period if they meet the screening criteria
Induction period at least 3 months Optimized treatment with RAS blockers is performed immediately upon entry the induction period
Randomization RAS blockers were used for at least 3 months during the induction period All inclusion conditions had to be met to qualify for randomization
Treatment period 9 months Participants who meet the randomization criteria will be randomly assigned 11 to receive probiotics combined with enteric-coated budesonide capsules group or probiotics placebo combined with enteric-coated budesonide capsules In the 9-month treatment period the following treatments will be received ① probiotics combined with enteric-coated budesonide capsules group 1 bagday of probiotics each bag added active probiotic Lactobacillus casei Zhang 100 billion CFU 16 mgday oral enteric-coated budesonide capsules ② probiotics placebo combined with enteric-coated budesonide capsules group 1 bagday of probiotics placebo 16 mgday oral enteric-coated budesonide capsules
The RAS blocker ACEI or ARB dosing regimen needs to be stable during treatment period
Reduction period 2 weeks 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 mgday oral enteric-coated budesonide capsules
The RAS blocker ACEI or ARB dosing regimen needs to be stable during reduction period
Safety follow-up period 25 months After completion of the reduction period all participants stopped taking the investigational drug completed the remainder of the safety follow-up period During this time the RAS blocker ACEI or ARB dosing regimen needs to be stable
Long-term follow-up period 36 months Participants who have completed the treatment period reduction period and safety follow-up period as well as those who terminated the study treatment early but did not withdraw from the study will enter long-term follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None