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> Web page: https://trialight.com/data/trial/a-phase-iii-clinical-study-on-the-efficacy-and-safety-of-hrs-d340fe7f-1d48-43d9-bc9b-068fb603f903
> Record changed: 2026-10-13

# A Phase III Clinical Study on the Efficacy and Safety of HRS-1780 in the Treatment of Patients With Chronic Kidney Disease

NCT07419828

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

Participants

5,386

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

Start date

2026-03-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

## Title and summary

**Summary**

The study is a Phase III clinical trial to evaluate the superiority of HRS-1780 tablets compared with placebo in delaying renal function decline in participants with chronic kidney disease (CKD) on the basis of standard treatment.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Short title**

A Phase III Clinical Study on the Efficacy and Safety of HRS-1780 in the Treatment of Patients With Chronic Kidney Disease

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Official title**

A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase III Study Evaluating the Efficacy and Safety of HRS-1780 in Adult Participants With Chronic Kidney Disease

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

## Dates

**Completion date**

2030-05-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**First posted**

2026-02-19

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Registry last updated**

2026-07-17

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Primary completion date**

2030-04-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Start date**

2026-03-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

## Size and sites

**Participants**

5,386

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Planned participants**

5,386

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Protocol amendments**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

## Sponsor and oversight

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Lead sponsor**

Shandong Suncadia Medicine Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

## Identifiers

**Registry ID**

NCT07419828

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**ClinicalTrials.gov ID**

NCT07419828

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

## Outcomes

### Primary outcomes

1. Time to the first appearance of the composite endpoint:  
Timeframe: month 60  
\* Progression of kidney disease (initiation of maintenance dialysis or receiving kidney transplantation or continuous eGFR \\<15 mL/min/1.73m², or death due to kidney disease or a ≥40% decrease in eGFR compared to baseline for at least 4 weeks); or \* CV Death.

### Secondary outcomes

1. The annualized total slope of eGFR from baseline to 36 months.  
Timeframe: month 36
2. The ratio of UACR to baseline at the 6th month .  
Timeframe: month 6
3. The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment.  
Timeframe: month 60

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

80 Years

**Healthy volunteers**

No

### Inclusion criteria

- Male or female, aged ≥18 and <80 years old on the day of signing the informed consent form;
- a) The estimated glomerular filtration rate calculated by the CKD-EPI 2009 formula of the Chronic Kidney Disease Epidemiology Collaboration was eGFR≥60 and <90 mL/min/1.73 m2, and UACR≥300 mg/g; Or b) eGFR≥30 and <60 mL/min/1.73 m2, and UACR≥30 mg/g ; Or c) eGFR≥25 and <30 mL/min/1.73 m2；
- Serum potassium ≤4.8 mmol/L
- HbA1c was less than 10.5%.

### Exclusion criteria

- Uncontrolled severe hypertension at the time of screening or randomization (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
- Alanine aminotransferase (ALT) >3× upper limit of normal (ULN); Aspartate aminotransferase (AST) >3×ULN; Total bilirubin >2.0×ULN;
- Diagnosis or suspicion of polycystic kidney disease, anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis;

Acute kidney injury occurred within 90 days before screening or hemodialysis or peritoneal dialysis treatment was received;

- Have received a kidney transplant in the past or plan to receive a kidney transplant during the trial period;
- There are diseases that may cause hyperkalemia during screening or randomization (such as Addison's disease);
- Within 180 days prior to the screening, the participants had the following diseases of clinical significance, which, as determined by the investigators, might interfere with the trial results or pose additional risks to the administration of the study drug: including but not limited to respiratory system, digestive system, cardiovascular and cerebrovascular, endocrine, immune, urinary, adrenal, blood, nervous, mental and other diseases;
- Stroke, transient ischemic attack, myocardial infarction, coronary revascularization, and decompensated heart failure (NYHA grade III-IV) occurred within 90 days before screening. And/or planned to undergo coronary, carotid or peripheral artery revascularization at the time of screening

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

## Sites

- National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing UniversityNanjing, ChinaRecruiting

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07419828)

## Related records

### Drugs (1)

- [Medroxyprogesterone acetate](https://trialight.com/data/asset/medroxyprogesterone-acetate-5514a525-6952-4a47-8871-8a2425a74366.md)

### Lead sponsors (1)

- [Shandong Suncadia Medicine Co., Ltd.](https://trialight.com/data/company/shandong-suncadia-medicine-co-ltd-c4ebee86-20f2-45b5-9857-30794a216c9a.md)

### Conditions (2)

- [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Primary condition
- [Kidney failure](https://trialight.com/data/condition/kidney-failure-f26737b4-3a55-50be-b6c3-b76514cb5067.md)

### Targets (1)

- [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md)

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