NephrotoxicityPhase 2NCT05673824
Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies.
A Phase 2 study testing Huaier Granule and VEGFR-TKIs in people with Nephrotoxicity, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, single-arm, single-center, exploratory study. The purpose of this study is to explore the effect of Huaier Granule on nephrotoxicity associated with anti-angiogenesis targeted therapy for advanced hepatobiliary malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotoxicity
- What is being tested?
- Huaier Granule and VEGFR-TKIs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2023to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Meeting the clinical diagnostic criteria of primary hepatobiliary malignancies, diagnosed as advanced hepatobiliary malignancies.
- Receiving VEGFR-TKIs for advanced hepatobiliary malignancies.
- Urinalysis indicates urine protein positive.
- Urine protein level greater than 0.3 grams and less than 3.5 grams per 24 hours.
- No Huaier granule were used within 1 month before enrollment.
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- Agree to use Huaier granule after enrollment.
- Expected survival time not less than 6 months.
- Volunteer to join the study and sign the informed consent form.
Who cannot join
- Allergic to the components of Huaier granule, or avoid to use Huaier granule or use with caution.
- Not able to take medication orally.
- Must use or are using drugs that may affect proteinuria other than VEGFR-TKIs, including but not limited to bevacizumab, ACEI, glucocorticoids (more than 3 weeks), traditional Chinese medicine (refer to drug instructions).
- Concomitant with other diseases that can lead to proteinuria, including but not limited to nephropathy, hypertension, urinary infections, systemic lupus erythematosus, multiple myeloma.
- Pregnant or lactating women or women prepare for pregnancy.
- Participating in clinical trials of other drugs that intend to treat proteinuria.
- Refused to cooperate with follow-up.
- Other reasons that the researcher considers unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: Effect of Huaier Granule on Nephrotoxicity Associated With Anti-angiogenesis Targeted Therapy for Advanced Hepatobiliary Malignancies: a Single-arm, Single-center, Exploratory Study.
This is a prospective, single-arm, single-center, exploratory study. The purpose of this study is to explore the effect of Huaier Granule on nephrotoxicity associated with anti-angiogenesis targeted therapy for advanced hepatobiliary malignancies.
Read the detailed description
China is a country with a high incidence of liver cancer, and the incidence of primary liver cancer ranks the fourth among malignant tumors in China. Hepatocellular carcinoma (HCC) is the main type of liver cancer, accounting for 75% to 85%. About 39.0%-53.6% of HCC patients were already advanced when first visit and had lost the opportunity to receive radical treatment. Currently, anti-angiogenesis targeted drugs are recommended for the first- or second-line treatment of advanced hepatocellular carcinoma. Biliary tract carcinoma are rare, accounting for about 3% of all digestive system malignancies. BTC are aggressive and were usually found in advanced stage, with a 5-year survival rate less than 5%. For advanced BTC, chemotherapy is the mainly systematic therapy recommended by current guidelines, targeted therapy and immunotherapy have shown efficacy in the exploration of the first-line and post-line of BTC. Anti-angiogenesis targeted drugs including lenvatinib are recommended for the first- or second-line treatment of advanced BTC.
Kidney injury is one of the common adverse reactions of anti-angiogenesis targeted drugs, among which proteinuria is one of the most common adverse reactions. Multiple key clinical studies have shown that the incidence of proteinuria associated with targeted therapy ranges from 10% to 51%, and the incidence of drug reduction or interruption due to proteinuria ranges from 0.9% to 17%.
Huaier is an extract from a medicinal fungus. The main effective component of Huai Qi Huang granule is Trametes Robiniophila Murr, which has been used in the treatment of chronic kidney disease for more than ten years. It was found that the effect of Huai Qi Huang granule alone or combined with RASI in the treatment of proteinuria was better than conventional treatment. The effective component of Huaier granule is also Trametes Robiniophila Murr, and its content is higher than that of Huai Qi Huang granule. Therefore, it is speculated that Huaier granule have a certain effect on anti-angiogenesis targeted therapy associated proteinuria in advanced hepatobiliary malignancies.
In this study, 1 research centers will participate. This study planned to enroll 53 participants. All the participants will be treated with Huaier granule. In this study, participants will be followed up for 24 weeks.
- Conditions
- Nephrotoxicity
- Being tested
- Huaier Granule, VEGFR-TKIs
- Keywords
- Huaier granule, proteinuria, hepatobiliary malignancies, anti-angiogenesis targeted therapy
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaier GranuleDrug
Treatment period: oral administration, 10g each time, 3 times a day. Continuous medication until the end of the study, failure of treatment, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first; or after researcher's judgement, patient would no longer benefit from the treatment.
If the treatment of hepatobiliary malignancies needs to be changed due to disease progression, whether to continue the medication or not should be determined by the researcher.
VEGFR-TKIsDrug
Treatment period: Therapeutic agents were selected according to clinical routine, including but not limited to Sorafenib, Lenvatinib, Donafenib, Regorafenib, Apatinib and Cabozantinib. Continuous medication until disease progression, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first. Refer to drug instructions for specific usage.
| Study group | Role | What they receive |
|---|---|---|
| Huaier Granule Group | Experimental | Huaier Granule+VEGFR-TKIs Receives: Drug: Huaier Granule; Drug: VEGFR-TKIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effective rate on proteinuria treatment after 8 weeks of Huaier granule
Proportion of subjects who achieved complete remission (CR) or partial remission (PR) or stable disease (SD) after 8 weeks treatment of Huaier granule.
Perform a 24-hour urine collection for protein measurement, CR is defined as urine protein level≤0.3g/24h; PR is defined as urine protein level>0.3g/24h and<3.5g/24h, and decrease more than 30% from baseline; SD is defined as urine protein level >0.3g/24h and<3.5g/24h, and decrease less than or equal to 30% from baseline (or increase less than or equal to 20% from baseline); treatment failure is defined as at least two 24-hour urine protein tests show an increase of urine protein level of more than 20% from baseline or≥3.5 g/24h, or admission to renal replacement therapy or death.
Measured: 8 weeks
Secondary outcomes (6)
Mean value of 24-hour urinary protein level change from baseline to 8 weeks treatment of Huaier granule
Mean value of the difference between baseline 24h urine protein level and the 24h urine protein level after 8 weeks treatment of Huaier granule.
Measured: 8 weeks
Mean value of 24-hour urinary protein level decrease rate from baseline to 8 weeks treatment of Huaier granule
Decrease rate: percentage of the difference between baseline 24h urine protein level and the 24h urine protein level after 8 weeks treatment of Huaier granule in baseline 24h urine protein level.
Measured: 8 weeks
Incidence and severity of renal adverse events (AE) after 8 weeks treatment of Huaier granule
Measured: 8 weeks
Incidence and severity of serious renal adverse events (SAE) after 8 weeks treatment of Huaier granule
Measured: 8 weeks
Incidence and severity of renal adverse events (AE) after 16 weeks treatment of Huaier granule
Measured: 16 weeks
Incidence and severity of serious renal adverse events (SAE) after 16 weeks treatment of Huaier granule
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start3 Jan 2023
- Primary completion16 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrotoxicityStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
- Investigators
- Lu Wang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673824
- Sponsor's protocol ID
- HE-202210
- Status last verified
- Feb 2026
- First submitted
- 21 Dec 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Huaier Granule on Nephrotoxicity Associated With Anti-angiogenesis Targeted Therapy for Advanced Hepatobiliary Malignancies: a Single-arm, Single-center, Exploratory Study.
- ClinicalTrials.gov ID
- NCT05673824
- Acronym / sponsor ID
- HE-202210
- Conditions
- Nephrotoxicity
- Keywords
- Huaier granule, proteinuria, hepatobiliary malignancies, anti-angiogenesis targeted therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 16 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm, single-center, exploratory study. The purpose of this study is to explore the effect of Huaier Granule on nephrotoxicity associated with anti-angiogenesis targeted therapy for advanced hepatobiliary malignancies.
Detailed description
China is a country with a high incidence of liver cancer, and the incidence of primary liver cancer ranks the fourth among malignant tumors in China. Hepatocellular carcinoma (HCC) is the main type of liver cancer, accounting for 75% to 85%. About 39.0%-53.6% of HCC patients were already advanced when first visit and had lost the opportunity to receive radical treatment. Currently, anti-angiogenesis targeted drugs are recommended for the first- or second-line treatment of advanced hepatocellular carcinoma. Biliary tract carcinoma are rare, accounting for about 3% of all digestive system malignancies. BTC are aggressive and were usually found in advanced stage, with a 5-year survival rate less than 5%. For advanced BTC, chemotherapy is the mainly systematic therapy recommended by current guidelines, targeted therapy and immunotherapy have shown efficacy in the exploration of the first-line and post-line of BTC. Anti-angiogenesis targeted drugs including lenvatinib are recommended for the first- or second-line treatment of advanced BTC.
Kidney injury is one of the common adverse reactions of anti-angiogenesis targeted drugs, among which proteinuria is one of the most common adverse reactions. Multiple key clinical studies have shown that the incidence of proteinuria associated with targeted therapy ranges from 10% to 51%, and the incidence of drug reduction or interruption due to proteinuria ranges from 0.9% to 17%.
Huaier is an extract from a medicinal fungus. The main effective component of Huai Qi Huang granule is Trametes Robiniophila Murr, which has been used in the treatment of chronic kidney disease for more than ten years. It was found that the effect of Huai Qi Huang granule alone or combined with RASI in the treatment of proteinuria was better than conventional treatment. The effective component of Huaier granule is also Trametes Robiniophila Murr, and its content is higher than that of Huai Qi Huang granule. Therefore, it is speculated that Huaier granule have a certain effect on anti-angiogenesis targeted therapy associated proteinuria in advanced hepatobiliary malignancies.
In this study, 1 research centers will participate. This study planned to enroll 53 participants. All the participants will be treated with Huaier granule. In this study, participants will be followed up for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Huaier Granule Group | Experimental | Drug: Huaier Granule, Drug: VEGFR-TKIsHuaier Granule+VEGFR-TKIs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years and older
- Meeting the clinical diagnostic criteria of primary hepatobiliary malignancies, diagnosed as advanced hepatobiliary malignancies.
- Receiving VEGFR-TKIs for advanced hepatobiliary malignancies.
- Urinalysis indicates urine protein positive.
- Urine protein level greater than 0.3 grams and less than 3.5 grams per 24 hours.
Key exclusion criteria (8 listed)
- Allergic to the components of Huaier granule, or avoid to use Huaier granule or use with caution.
- Not able to take medication orally.
- Must use or are using drugs that may affect proteinuria other than VEGFR-TKIs, including but not limited to bevacizumab, ACEI, glucocorticoids (more than 3 weeks), traditional Chinese medicine (refer to drug instructions).
- Concomitant with other diseases that can lead to proteinuria, including but not limited to nephropathy, hypertension, urinary infections, systemic lupus erythematosus, multiple myeloma.
- Pregnant or lactating women or women prepare for pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huaier GranuleTreatment period: oral administration, 10g each time, 3 times a day. Continuous medication until the end of the study, failure of treatment, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first; or after researcher's judgement, patient would no longer benefit from the treatment. If the treatment of hepatobiliary malignancies needs to be changed due to disease progression, whether to continue the medication or not should be determined by the researcher. | Drug | Huaier Granule Group |
| VEGFR-TKIsTreatment period: Therapeutic agents were selected according to clinical routine, including but not limited to Sorafenib, Lenvatinib, Donafenib, Regorafenib, Apatinib and Cabozantinib. Continuous medication until disease progression, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first. Refer to drug instructions for specific usage. | Drug | Huaier Granule Group |
Primary outcome
The effective rate on proteinuria treatment after 8 weeks of Huaier granule
Time frame: 8 weeks
Proportion of subjects who achieved complete remission (CR) or partial remission (PR) or stable disease (SD) after 8 weeks treatment of Huaier granule. Perform a 24-hour urine collection for protein measurement, CR is defined as urine protein level≤0.3g/24h; PR is defined as urine protein level>0.3g/24h and<3.5g/24h, and decrease more than 30% from baseline; SD is defined as urine protein level >0.3g/24h and<3.5g/24h, and decrease less than or equal to 30% from baseline (or increase less than or equal to 20% from baseline); treatment failure is defined as at least two 24-hour urine protein tests show an increase of urine protein level of more than 20% from baseline or≥3.5 g/24h, or admission to renal replacement therapy or death.
6 secondary outcomes
Mean value of 24-hour urinary protein level change from baseline to 8 weeks treatment of Huaier granule
Time frame: 8 weeks
Mean value of 24-hour urinary protein level decrease rate from baseline to 8 weeks treatment of Huaier granule
Time frame: 8 weeks
Incidence and severity of renal adverse events (AE) after 8 weeks treatment of Huaier granule
Time frame: 8 weeks
Incidence and severity of serious renal adverse events (SAE) after 8 weeks treatment of Huaier granule
Time frame: 8 weeks
Incidence and severity of renal adverse events (AE) after 16 weeks treatment of Huaier granule
Time frame: 16 weeks
Incidence and severity of serious renal adverse events (SAE) after 16 weeks treatment of Huaier granule
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Wang principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Huaier Granule and VEGFR-TKIs in people with Nephrotoxicity, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effective rate on proteinuria treatment after 8 weeks of Huaier granule (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.