drugset / Trial / NCT07355361

Huaier Granule and Proteinuria

NCT07355361

Phase 2 Not yet recruiting 120 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-01-15
Primary completion
2027-06-15
Completion
2028-06-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Huaier Granule Traditional medicine (herbal / TCM) 10 g Oral