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Clinical evidence-based evaluation of the treatment of ICIs-AKI of qi deficiency and blood stasis type with Hushen Xiaoyu Mixture

Clinical evidence-based evaluation of the treatment of ICIs-AKI of qi deficiency and blood stasis type with Hushen Xiaoyu Mixture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000337
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-11-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute kidney injury associated with immune checkpoint inhibitors

Interventions

treatment group:Western medicine standard treatment + Kidney Protection and Blood Stasis Dissolving Granules
control group:Western medicine standard treatment

Sponsors

the First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Clinically and pathologically diagnosed as a malignant tumor; 2) Age between 18 and 75 years old; 3) Received ICIs treatment (treatment plan follows the "2024 CSCO Clinical Application Guidelines for Immune Checkpoint Inhibitors", can be used alone or in combination, and does not combine with cisplatin); 4) Evaluated by a specialist doctor with intermediate or higher professional title in nephrology, the patient meets the diagnosis of AKI, and AKI can be directly attributed to ICIs; 5) ICIs-AKI stage is within the G1-G3 period of the ICI renal toxicity stage as defined in the "2023 CSCO Guidelines for the Management of Toxicity Associated with Immune Checkpoint Inhibitors in Clinical Oncology"; 6) The patient or the patient's authorized person has given informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those who have been clearly diagnosed with other drug-related kidney damage within the past three months; 2) Those whose data is severely incomplete and cannot be evaluated.

Design outcomes

Primary

MeasureTime frame
24-hour urinary protein quantity;Epidermal Growth Factor Receptor;Urine CXCL9;Syndrome score of qi deficiency and blood stasis syndrome;microalbuminuria;Traditional Chinese Medicine Syndrome Score;Cumulative dose of glucocorticoid use;Anti-tumor efficacy indicators;Urine protein qualitative test;blood urea nitrogen;serum creatinine;—

Secondary

MeasureTime frame
ECG;blood fat;blood routine examination;blood glucose;vital signs;liver function;—

Countries

China

Contacts

Public ContactXiangfu Gao

Zhejiang Provincial Hospital Of Chinese Medicine

gaoxf6016@126.com135 0571 6016

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026