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New treatment option for Nephropathy
Official title Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy
ClinicalTrials.gov ID: NCT05839314
What this study is testing
What is Huaier granule?
Huaier granule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nephropathy.
Also referred to as Jinke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- The eGFR≥45ml/min/1.73m2 (Measured at least twice in 2 weeks);
You likely can't join 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;
See the full eligibility criteria
- 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.
- 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...
- 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 how well it works and safety evaluation;
- Pregnant or lactating women, and patients (male or female) with fertility plans or unwilling to take effective contraceptive measures;
- Participating in other clinical trials or participated in other clinical studies within 3 months;
- According to the researchers, patients have diseases or conditions that increase the difficulty of enrollment or probability of loss to follow-up, such as mental illness, frequent changes in residence and work, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.