A Phase 4 interventional study of probiotics combined with enteric-coated budesonide capsule and probiotics placebo combined with enteric-coated budesonide capsules in Glomerulonephritis, IGA, Probiotics and Budesonide, sponsored by Gang Xu. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Gang Xu · Phase 4, Interventional, and Treatment
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 9.5 month Participate in center site follow-up visits for 13 times Keep a diary of their symptoms and outcomes
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 (2.5 months), and a long-term follow-up period (36 months). Participants who meet the randomization criteria will be randomly assigned (1:1) 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 (1:1) 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 bag/day of probiotics (each bag added active probiotic Lactobacillus casei Zhang ≥100 billion CFU) +16 mg/day oral enteric-coated budesonide capsules. ② probiotics placebo combined with enteric-coated budesonide capsules group: 1 bag/day of probiotics placebo +16 mg/day 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 mg/day oral enteric-coated budesonide capsules.
The RAS blocker (ACEI or ARB) dosing regimen needs to be stable during reduction period.
Safety follow-up period (2.5 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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 206 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →This is the only study on the registry with Gang Xu as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental participants will receive probiotics combined with enteric-coated budesonide capsules
Drug: probiotics combined with enteric-coated budesonide capsule
Comparator participants will receive probiotics placebo combined with 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 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.
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.
UPCR
Mean change from baseline in UPCR over the 9-month treatment phase
Time frame: over the 9-month treatment phase
UPCR
Mean change from baseline in UPCR at 12 months
Time frame: at 12 months
24-h urine protein excretion
Mean changes from baseline in 24-h urine protein excretion at 9 and 12 months
Time frame: at 9 and 12 months
UACR
Mean changes from baseline in UACR at 9 and 12 months
Time frame: at 9 and 12 months
serum Gd-IgA1
Mean changes from baseline in serum Gd-IgA1 at 3, 6, 9 and 12 months
Time frame: at 3, 6, 9 and 12 months
serum BAFF and APRIL
Mean changes from baseline in serum BAFF and APRIL at 12 months
Time frame: at 12 months
eGFR
Mean changes from baseline in eGFR at 9 and 12 months
Time frame: at 9 and 12 months
eGFR
Changes from baseline in eGFR at each visit during long-term follow-up
Time frame: 12months，24months，36months after the end of treatment
UACR
Changes from baseline in UACR at each visit during long-term follow-up
Time frame: 12months，24months，36months after the end of treatment
24-h urine protein excretion
Changes from baseline in 24-h urine protein excretion at each visit during long-term follow-up
Time frame: 12months，24months，36months after the end of treatment
renal function (including creatinine, urea, and uric acid)
Changes from baseline in renal function (including creatinine, urea, and uric acid) at each visit during long-term follow-up
Time frame: 12months，24months，36months after the end of treatment
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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