A Phase 4 interventional study of Huaier granule and Renin-angiotensin-aldosterone system inhibitors (RASI) in Nephropathy, Glomerular Diseases and Idiopathic Membranous Nephropathy, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Chinese PLA General Hospital · Phase 4, Interventional, and Treatment
This is a prospective, multicenter, randomized, open-label, parallel controlled study. The purpose of this study is to evaluate the efficacy and safety of Huaier granule on the treatment of idiopathic membranous nephropathy comparing with Ciclosporin soft capsules.
Idiopathic membranous nephropathy (IMN) is a common immune-mediated glomerular disease, accounting for 20% to 36.8% of adult nephrotic syndrome. A third of the patients will experience complete remission spontaneously, and 30%-40% of patients will develop chronic renal failure. The treatment of IMN includes supportive therapy and immunosuppressive therapy. Ciclosporin (CsA) is a kind of calcineurin inhibitor (CNI) recommended by the Kidney disease improving global outcomes (KDIGO) clinical practice guideline for IMN treatment. CsA is effective in inducing remission among patients with steroid-resistant nephrotic IMN, and studies showed the clinical remission rate was 60%-75%. However, it has a high rate of relapse during follow-up in 6-12 months.
Huaier granule is an extract from a medicinal fungus. Previous studies showed that Huaier granule reduced the excretion of proteinuria, inhibited inflammation and cellular transdifferentiation, and protect renal function.
In this study, about 30 research centers will participate. We plan to enroll 480 participants (240 cases in the experimental group and 240 cases in the control group). The planned length of patient recruitment enrolment will be 2 years and the total length of visits be 1 year.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 480 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will take Huaier granule and renin-angiotensin-aldosterone system inhibitors (RASI).
Drug: Huaier granule · Drug: Renin-angiotensin-aldosterone system inhibitors (RASI)
Patients will take Ciclosporin soft capsules and RASI.
Drug: Renin-angiotensin-aldosterone system inhibitors (RASI) · Drug: Ciclosporin soft capsules
Huaier granule, oral administration, 10g each time, 3 times a day, continuous medication for 24 weeks. After 24 weeks of treatment, the dosage should be adjusted according to efficacy.
Also known as: Jinke
Run-in period: All the patients should be treated with RASI for at least 4 weeks, and stop using any medicine containing Huaier or similar ingredients for at least 2 weeks before enrollment. If the patient is receiving RASI, the RASI can be continued until the end of the study. RASI can be adjusted once a week until the maximum tolerable dose based on albuminuria and blood pressure. If the patient is not receiving RASI therapy, then RASI is recommended. Treatment period: RASI therapy is continued throughout the trial. Check blood pressure twice daily: morning and evening.
The initial dose of Ciclosporin soft capsules is an oral dose of 3.5mg/kg/d, divided into two equal doses, given every 12 hours. Assess the plasma concentration of CsA (valley value) every 2 weeks in the first 8 weeks. If the plasma concentration of CsA reaches 100-150ug/L, continue to maintain the dose. If the plasma concentration of CsA is below the target concentration, increase the dose of CsA. If the plasma concentration of CsA is higher than the upper limit of the target concentration, appropriate dose reduction. A single dose adjustment is 25mg/d. After increasing/decreasing the dose, CsA concentration is remeasured at intervals of 2 weeks ±3 days until the target concentration is reached. CsA at target concentration followed by 24 weeks of treatment, then the dosage shall be adjusted according to efficacy.
Overall clinical remission rate at 24, 48, 96 weeks
Overall clinical remission rate is defined as rate of complete remission and partial remission. Complete remission is defined as a 24-h urinary protein level \< 0.3g/d with normal serum albumin level and stable renal function. Partial remission is defined as 24-h urinary protein level \< 3.5g/d with peak value reduction ≥ 50%, accompanied by improved or normal serum albumin, stable renal function.
Time frame: Start of randomization until 96 weeks
Rate of complete remission at 24, 48, 96 weeks
The rate of patients achieve complete remission at 24, 48, or 96 weeks.
Time frame: Start of randomization until 96 weeks
Rate of partial remission at 24, 48, 96 weeks
The rate of patients achieve partial remission at 24, 48, or 96 weeks.
Time frame: Start of randomization until 96 weeks
Median time to achieve complete remission
Time frame: Start of randomization until 96 weeks
Median time to achieve partial remission
Time frame: Start of randomization until 96 weeks
Median time of the first relapse of nephrotic syndrome for patients who achieve complete remission or partial remission
Time frame: Start of randomization until 96 weeks
Proportion of patients with relapse of nephrotic syndrome
Time frame: Start of randomization until 96 weeks
Rate of treatment failure at the end of the study
Treatment failure: the efficacy has not reached complete or partial remission
Time frame: Start of randomization until 96 weeks
The proportion of reappearance proteinuria (but not reach nephrotic syndrome) for patients with complete response
Time frame: Start of randomization until 96 weeks
The 24-hour urinary protein level and changes from baseline at 24, 48, 96 weeks
Time frame: Start of randomization until 96 weeks
The serum albumin level and changes from baseline at 24, 48, 96 weeks
Time frame: Start of randomization until 96 weeks
Changes of serum creatinine at 24, 48, 96 weeks
Time frame: Start of randomization until 96 weeks
Changes of blood urea nitrogen at 24, 48, 96 weeks
Time frame: Start of randomization until 96 weeks
Changes of serum uric acid at 24, 48, 96 weeks
Time frame: Start of randomization until 96 weeks
Changes of serum blood lipid level at 24, 48, 96 week
Time frame: Start of randomization until 96 weeks
The level and changes of estimated glomerular filtration rate (eGFR) calculating using the CKD-EPI formula at 24, 48, 96 weeks
Time frame: Start of randomization until 96 weeks
Percentage of patients who serum creatinine doubled for 12 weeks, progress to end-stage renal disease, or receive renal replacement therapy
Time frame: Start of randomization until 96 weeks
The number and proportion of patients who died for any reason
Time frame: Start of randomization until 96 weeks
The level of phospholipase A2 receptor (PLA2R) and changes from baseline at 24, 48, 96 weeks
Time frame: Start of randomization until 96 weeks
The level and changes of immunoglobulin and complement
Time frame: Start of randomization until 96 weeks
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: Start of randomization until 96 weeks
Incidence and severity of adverse reactions (ADR), serious adverse reactions (SADR)
Time frame: Start of randomization until 96 weeks
Plan to share: No
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