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:
Fudan University
Organization:
Study Overview
Official Title:
Multicenter, Randomized, Parallel-Controlled Clinical Trial on Huaier Granule for Proteinuria Associated With Immunotherapy and Anti-Angiogenic Therapy in Breast Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
N093
Brief Summary:
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.
The main question it aims to answer is:
\* Does the addition of Huaier Granule to standard care improve the effectiveness of proteinuria treatment after 8 weeks?
Researchers 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.
Participants will:
* Be randomly assigned to one of the two study groups.
* Continue their prescribed anti-cancer therapy (immunotherapy or anti-angiogenic therapy).
* Receive standard medical care for proteinuria from a kidney specialist.
* If in the experimental group, take Huaier Granule orally, three times a day.
* Attend clinic visits every 4 weeks for up to 24 weeks for check-ups and tests, including urine and blood tests.
The main question it aims to answer is:
\* Does the addition of Huaier Granule to standard care improve the effectiveness of proteinuria treatment after 8 weeks?
Researchers 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.
Participants will:
* Be randomly assigned to one of the two study groups.
* Continue their prescribed anti-cancer therapy (immunotherapy or anti-angiogenic therapy).
* Receive standard medical care for proteinuria from a kidney specialist.
* If in the experimental group, take Huaier Granule orally, three times a day.
* Attend clinic visits every 4 weeks for up to 24 weeks for check-ups and tests, including urine and blood tests.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: