Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy

NCT05839314 | Recruiting Phase 4

• 1 other identifier: HE-202009
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nephropathy; Glomerular Diseases; Idiopathic Membranous Nephropathy

Keywords

Huaier granule; Ciclosporin; Idiopathic membranous nephropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  Start of randomization until 96 weeks

Secondary Outcomes (21)

• Rate of complete remission at 24, 48, 96 weeks

  Start of randomization until 96 weeks

• Rate of partial remission at 24, 48, 96 weeks

  Start of randomization until 96 weeks

• Median time to achieve complete remission

  Start of randomization until 96 weeks

• Median time to achieve partial remission

  Start of randomization until 96 weeks

• Median time of the first relapse of nephrotic syndrome for patients who achieve complete remission or partial remission

  Start of randomization until 96 weeks

Study Arms (2)

Huaier group

EXPERIMENTAL

Patients will take Huaier granule and renin-angiotensin-aldosterone system inhibitors (RASI).

Drug: Huaier granule; Drug: Renin-angiotensin-aldosterone system inhibitors (RASI)

Ciclosporin soft capsules group

ACTIVE COMPARATOR

Patients will take Ciclosporin soft capsules and RASI.

Drug: Renin-angiotensin-aldosterone system inhibitors (RASI); Drug: Ciclosporin soft capsules

Interventions

Huaier granule DRUG

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

Huaier group

Renin-angiotensin-aldosterone system inhibitors (RASI) DRUG

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.

Ciclosporin soft capsules group; Huaier group

Ciclosporin soft capsules DRUG

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.

Ciclosporin soft capsules group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Renal biopsy was performed before randomization and pathologically diagnosed as idiopathic membranous nephropathy;
• Anti-phospholipase a2 receptor (PLA2R) antibody is positive;
• Aged from 18 to 75, either sex;
• Tolerable doses of RASI were received for ≥4 weeks before randomization, nephrotic syndrome was not in remission and 24-hour urinary protein level was ≥3.5g/24h and \< 8.0g/24h;
• The eGFR≥45ml/min/1.73m2 (Measured at least twice in 2 weeks);
• The patient is willing to sign the informed consent form.

You may not qualify if:

• Diagnosed as secondary membranous nephropathy;
• Rapidly progressive membranous nephropathy (eGFR decreased by 50 % compared with the baseline level within 3 months);
• Receiving renal replacement therapy;
• Diabetes and glycosylated hemoglobin (HbA1c) levels ≥ 7.0%;
• Hypertension is not well controlled (systolic blood pressure\>160mmHg or diastolic blood pressure\>100mmHg);
• The level of serum albumin≤20g/L;
• Resistance to treatment with CsA or other CNI, rituximab (RTX) or alkylating agents; complete remission or partial remission was obtained after treatment with CNI, RTX, or alkylating agents but there was a history of relapse within 3 months；
• Suspected infection by imaging and/or laboratory tests;
• Infectious diseases, such as hepatitis B, hepatitis C, AIDS, tuberculosis;
• History of malignant tumor;
• Hepatic dysfunction: aspartate aminotransferase (AST) concentration and alanine aminotransferase (ALT) concentration of \> 1.5 × upper limit of normal;
• Allergic to Huaier granule or Ciclosporin soft capsules;
• Previous CNI treatment was ineffective;
• Complicate with any diseases that may affect efficacy and safety evaluation;
• Pregnant or lactating women, and patients (male or female) with fertility plans or unwilling to take effective contraceptive measures;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• LinkDoc Technology (Beijing) Co. Ltd.: collaborator
• Huazhong University of Science and Technology: collaborator

Study Sites (1)

Chinese PLA general hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Kidney Diseases; Glomerulonephritis, Membranous

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiangmei Chen, PhD

  Chinese PLA General Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangmei Chen, PhD

CONTACT

00-86-010-66937166; shengdai26@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: May 9, 2023
• Primary Completion (Estimated): May 3, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)