Chronic Kidney DiseasePhase 2NCT06221059
Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease
A Phase 2 study of Chronic Kidney Disease, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The objective of this study was to evaluate the efficacy of HRS-1780 tablets or Henagliflozin Proline tablets in patients with chronic kidney disease by evaluating UACR change from baseline to Week 13 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2024to 24 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-75 years old
- Body mass index (BMI) ≥18.0 and <50.0 kg/m2 at the screening visit
- Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
- Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and <90 mL/min/1.73 m2 calculated using the CKD-EPI formula at the screening visit
- Urinary albumin/creatinine ratio (UACR) was ≥300 and <3000 mg/g for at least 2 times on different days detected by the local laboratory; at the screening visit
- HbA1c <9.0% at the screening visit
Who cannot join
- A known or suspected allergy to the investigational drug or its components or excipients;
- Receive a potent inhibitor/inducer of cytochrome P450 3A4 (CYP3A4) within 7 days prior to screening;
- Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs, endothelin receptor antagonists;
- Receive SGLT-2 or SGLT-1/2 inhibitors within 4 weeks before screening
- Received glucagon-like peptide-1 receptor agonist (GLP-1RA) within 8 weeks before screening
- Received systemic glucocorticoid therapy within 3 months before screening
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- Received immunosuppressive drugs or biological agents
- Received any other study drug treatment within 3 months or 5 half-lives prior to screening
- Severe hypertension that was not controlled at screening visit or random visit (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), or systolic blood pressure <90 mmHg
- Have urinary tract infection or/and genital infection at the screening visit or random visit, or have a history of repeated urinary tract infection or/and genital infection
- Diagnosed or suspected polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;
- Acute kidney injury or dialysis treatment within 6 months before screening
- Received kidney transplant, or plan to receive kidney transplant during the trial
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210002
About this study
Official title: A Phase II Clinical Study of Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in the Treatment of Patients With Chronic Kidney Disease (Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Design)
The objective of this study was to evaluate the efficacy of HRS-1780 tablets or Henagliflozin Proline tablets in patients with chronic kidney disease by evaluating UACR change from baseline to Week 13
- Conditions
- Chronic Kidney Disease
- Being tested
- HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placeboDrug
Drug：HRS-1780 tablet Drug：Henagliflozin Proline tablet Drug：HRS-1780 tablet placebo Drug：Henagliflozin Proline tablet placebo
| Study group | Role | What they receive |
|---|---|---|
| HRS-1780 dose 1 | Experimental | Not described Receives: Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo |
| HRS-1780 dose 2 | Experimental | Not described Receives: Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo |
| Henagliflozin Proline | Active comparator | Not described Receives: Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 13 in UACR
Measured: From Baseline to Week 13
Secondary outcomes (5)
Change From Baseline to Week 13 in UACR category （>20%, >30%, >40%)
Measured: From Baseline to Week 13
Change From Baseline to Week 4, Week 7 in UACR
Measured: From Baseline to Week 4, Week 7
Change From Baseline to Week 13 in 24-hour urinary protein quantification
Measured: From Baseline to Week 13
Change From Baseline to Week 13 in estimated glomerular filtration rate (eGFR). An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Measured: From Baseline to Week 13
Change From Baseline to Week 13 in blood pressure
Measured: From Baseline to Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start2 Mar 2024
- Primary completion5 Mar 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221059
- Sponsor's protocol ID
- HRS-1780-201
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2024
- Last updated
- 1 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in the Treatment of Patients With Chronic Kidney Disease (Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Design)
- ClinicalTrials.gov ID
- NCT06221059
- Acronym / sponsor ID
- HRS-1780-201
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 24 Jan 2024 (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.
The objective of this study was to evaluate the efficacy of HRS-1780 tablets or Henagliflozin Proline tablets in patients with chronic kidney disease by evaluating UACR change from baseline to Week 13
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HRS-1780 dose 1 | Experimental | Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo |
| HRS-1780 dose 2 | Experimental | Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo |
| Henagliflozin Proline | Active comparator | Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo |
| Placebo | Placebo comparator | Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18-75 years old
- Body mass index (BMI) ≥18.0 and <50.0 kg/m2 at the screening visit
- Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
- Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and <90 mL/min/1.73 m2 calculated using the CKD-EPI formula at the screening visit
- Urinary albumin/creatinine ratio (UACR) was ≥300 and <3000 mg/g for at least 2 times on different days detected by the local laboratory; at the screening visit
Key exclusion criteria (13 listed)
- A known or suspected allergy to the investigational drug or its components or excipients;
- Receive a potent inhibitor/inducer of cytochrome P450 3A4 (CYP3A4) within 7 days prior to screening;
- Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs, endothelin receptor antagonists;
- Receive SGLT-2 or SGLT-1/2 inhibitors within 4 weeks before screening
- Received glucagon-like peptide-1 receptor agonist (GLP-1RA) within 8 weeks before screening
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 |
|---|---|---|
| HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placeboDrug：HRS-1780 tablet Drug：Henagliflozin Proline tablet Drug：HRS-1780 tablet placebo Drug：Henagliflozin Proline tablet placebo | Drug | HRS-1780 dose 1, HRS-1780 dose 2, Henagliflozin Proline, Placebo |
Primary outcome
Change From Baseline to Week 13 in UACR
Time frame: From Baseline to Week 13
5 secondary outcomes
Change From Baseline to Week 13 in UACR category （>20%, >30%, >40%)
Time frame: From Baseline to Week 13
Change From Baseline to Week 4, Week 7 in UACR
Time frame: From Baseline to Week 4, Week 7
Change From Baseline to Week 13 in 24-hour urinary protein quantification
Time frame: From Baseline to Week 13
Change From Baseline to Week 13 in estimated glomerular filtration rate (eGFR). An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Time frame: From Baseline to Week 13
Change From Baseline to Week 13 in blood pressure
Time frame: From Baseline to Week 13
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 1 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 of Chronic Kidney Disease, run by Shandong Suncadia Medicine Co., Ltd. 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 6 inclusion and 13 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 1 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
Change From Baseline to Week 13 in UACR (time frame: From Baseline to Week 13). 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 1 Dec 2025.