Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:26 AM
Study NCT ID:
NCT07355361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Huaier Granule and Proteinuria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate of proteinuria treatment at Week 8', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks.', 'description': 'The proportion of subjects (across both groups) achieving a best overall response of Complete Response, Partial Response, or Stable Disease in proteinuria at 8 weeks.'}], 'secondaryOutcomes': [{'measure': 'Response rate of proteinuria treatment at Week 16', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks', 'description': 'Response rate at Week 16 (defined as the proportion of subjects with complete response, partial response, or stable disease in proteinuria)'}, {'measure': 'Change from baseline in 24-hour urinary protein quantification at Weeks 8 and 16', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks', 'description': 'The between-group difference in the mean change from baseline in 24-hour urinary protein quantification at Week 8.'}, {'measure': 'Mean percent reduction in 24-hour urinary protein quantification at Weeks 8 and 16', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks', 'description': 'The mean of the percentage change, which is calculated for each subject as: (Baseline 24-hour urinary protein value - Week 8 value) / Baseline value × 100%, averaged across all subjects in both the experimental and control groups.'}, {'measure': 'Other Renal Adverse Events at Weeks 8 and 16', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks', 'description': 'The incidence and severity of other renal adverse events (including but not limited to elevated blood pressure, increased serum creatinine, elevated blood urea nitrogen, acute kidney injury, nephritis, nephrotic syndrome, and renal failure) are defined as follows:\n\nIncidence is defined as the proportion of subjects experiencing any of the specified other renal adverse events within the respective total population.\n\nSeverity will be graded according to the criteria described in the section for definitions and assessment of adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['proteinuria', 'Immunotherapy', 'Anti-angiogenic therapy', 'Breast cancer patients'], 'conditions': ['Proteinuria', 'Breast Cancer Patients']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if adding Huaier Granule to standard care can treat proteinuria (excess protein in the urine) in adult female breast cancer patients (aged 18-75) who developed this condition as a side effect of their immunotherapy or anti-angiogenic cancer treatment.\n\nThe main question it aims to answer is:\n\n\\* Does the addition of Huaier Granule to standard care improve the effectiveness of proteinuria treatment after 8 weeks?\n\nResearchers will compare the group receiving standard care plus Huaier Granule to the group receiving standard care alone to see if the combination is more effective at reducing protein levels in the urine.\n\nParticipants will:\n\n* Be randomly assigned to one of the two study groups.\n* Continue their prescribed anti-cancer therapy (immunotherapy or anti-angiogenic therapy).\n* Receive standard medical care for proteinuria from a kidney specialist.\n* If in the experimental group, take Huaier Granule orally, three times a day.\n* Attend clinic visits every 4 weeks for up to 24 weeks for check-ups and tests, including urine and blood tests.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\*\\*Inclusion Criteria\\*\\*\n\n 1. Female patients aged 18-75 years.\n 2. Histopathologically confirmed diagnosis of breast cancer.\n 3. Currently receiving or having a prior history of immunotherapy and/or anti-angiogenic therapy.\n 4. First-time detection of proteinuria on urinalysis, graded as +, ++, or +++.\n 5. 24-hour urinary protein quantification between 0.15g and 3.5g (exclusive).\n 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 7. Karnofsky Performance Status (KPS) score ≥70.\n 8. No prior treatment with Huaier Granule within one month before enrollment.\n 9. Life expectancy of at least 6 months.\n 10. Willingness to voluntarily participate in the study and provision of signed informed consent.\n\nExclusion Criteria:\n\n* \\*\\*Exclusion Criteria\\*\\*\n\n 1. Known history of chronic kidney disease (eGFR \\<60 ml/min/1.73m²) or diabetic nephropathy.\n 2. Proteinuria attributed to other diseases, including but not limited to primary renal disease, hypertension, urinary tract infection, systemic lupus erythematosus, or multiple myeloma.\n 3. Current use of ACEI/ARB medications (unless the dosage has been stable for ≥4 weeks prior to enrollment).\n 4. Known allergy, contraindication, or specific precaution to any component of Huaier Granule.\n 5. Women who are pregnant, breastfeeding, or planning to conceive.\n 6. Concurrent participation in any other clinical trial investigating medications for proteinuria.\n 7. Any other condition that, in the judgment of the investigator, would make the patient unsuitable for participation in this study.'}, 'identificationModule': {'nctId': 'NCT07355361', 'acronym': 'N093', 'briefTitle': 'Huaier Granule and Proteinuria', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Multicenter, Randomized, Parallel-Controlled Clinical Trial on Huaier Granule for Proteinuria Associated With Immunotherapy and Anti-Angiogenic Therapy in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'SCHBCC-N093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A Group', 'description': 'Antitumor therapy + Proteinuria management + Huaier Granule treatment', 'interventionNames': ['Drug: Huaier Granule', 'Drug: Antitumor therapy', 'Drug: Proteinuria Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B Group', 'description': 'Proteinuria management + Huaier Granule treatment', 'interventionNames': ['Drug: Antitumor therapy', 'Drug: Proteinuria Management']}], 'interventions': [{'name': 'Huaier Granule', 'type': 'DRUG', 'description': "Huaier Granule Group: Participants will take Huaier Granule (Z20000109) on top of their standard treatment. The dosing is 10g, orally, three times a day. Treatment continues until the study ends, or an event such as disease progression, unacceptable side effects, withdrawal, or death occurs, whichever comes first. The investigator can also stop treatment if it's no longer deemed beneficial. Refer to the drug label for details. The investigator will decide on continued use if the background cancer therapy is changed due to progression.", 'armGroupLabels': ['A Group']}, {'name': 'Antitumor therapy', 'type': 'DRUG', 'description': 'The pre-existing regimen started before enrollment, subject to adjustment based on clinical routine.', 'armGroupLabels': ['A Group', 'B Group']}, {'name': 'Proteinuria Management', 'type': 'DRUG', 'description': 'Specialist-managed care (including follow-up or drug therapy \\[excluding Huaier Granule\\]) initiated post-proteinuria diagnosis.', 'armGroupLabels': ['A Group', 'B Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'role': 'CONTACT', 'email': 'JIPENG_1010@163.COM'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhi-Ming Shao, MD, PhD', 'role': 'CONTACT', 'email': 'zhi_ming_shao@163.com', 'phone': '+86-021-64175590'}, {'name': 'Peng Ji, Dr.', 'role': 'CONTACT', 'email': 'JIPENG_1010@163.COM'}], 'overallOfficials': [{'name': 'Zhi-Ming Shao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Breast Surgery Department', 'investigatorFullName': 'Zhimin Shao', 'investigatorAffiliation': 'Fudan University'}}}}