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Recruiting Phase 4

A Research Study Looking at Kidney and Heart Health in Adults With Type 2 Diabetes and Chronic Kidney Disease Treated With Semaglutide in China

NCT07900438 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2026-10-12
Last updated
2026-10-28

Condition(s) studied

Cardiovascular RiskChronic Kidney Disease

Investigational drug(s) / intervention(s)

Semaglutide →

Semaglutide: Semaglutide is administered subcutaneously once weekly.

Study summary

The purpose of this clinical study is to find out what happens to kidney and heart health during treatment with a medicine called semaglutide, which is given as an injection under the skin. The clinical study will also look at whether this medicine is safe for adults who have type 2 diabetes (T2D) and chronic kidney disease (CKD). This study will last for about 60 to 172 weeks.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age 18 years or above at the time of signing the informed consent 2. Diagnosed with type 2 diabetes (T2D) 3. HbA1c less than or equal to (≤) 10 % (≤ 86 millimoles per mole \[mmol/mol\]) 4. Kidney impairment defined either by: * serum creatinine-based eGFR greater than or equal to (≥) 50 and less than or equal to (≤) 75 mL/min/1.73 m\^2 (CKD-EPI, 2009) and UACR greater than (\>) 300 and less than (\<) 5000 milligrams per gram (mg/g) or * serum creatinine-based eGFR ≥ 25 and \< 50 mL/min/1.73 m\^2 (CKD-EPI, 2009) and UACR \> 100 and \< 5000 mg/g 5. Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of inclusion criterion and kept stable until screening. Laboratory results for inclusion can be based on: * measurements no more than 90 days old at screening, documented in medical records or * central laboratory measurement obtained at the screening visit If using UACR and eGFR values from medical records for inclusion, these values must be entered in the electronic case report form. The number of participants with inclusion eGFR ≥ 60 mL/min/1.73 m\^2 will be capped at 20% of enrolled participants. Exclusion Criteria: 1. Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations. 2. Use of any glucagon-like peptide-1 receptor agonist (GLP1 RA) within 30 days prior to screening. This also includes dual agonists containing a GLP1 RA component. 3. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening. 4. Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis. 5. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination and optical coherence tomography performed within the past 90 days prior to screening or in the period between screening and enrolment. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for nondilated examination. 6. Combination use of an angiotensin-converting enzyme inhibitor and an angiotensin-II receptor blocker (ARB).

Primary outcome measure(s)

  • Time to first occurrence of a composite endpoint consisting of: Onset of persistent reduction of ≥ 50% in eGFR compared with baseline, Onset of persistent eGFR < 15 mL/min/1.73 m^2, Initiation of chronic kidney replacement therapy, Kidney death, CV death — From Baseline (Week 0) up to Week 169
    Measured in month(s)

Trial sites (26)

FacilityCityRegionStatus
Fu Yang People's Hospital-Nephrology Fuyang Anhui Not Yet Recruiting
Beijing Anzhen Hospital, Capital Medical University-Nephrology Beijing Beijing Municipality Recruiting
Peking University First Hospital-Nephrology Beijing Beijing Municipality Not Yet Recruiting
Beijing Friendship Hospital, Capital Medical University-Nephrology Beijing Beijing Municipality Not Yet Recruiting
The Second Hospital & Clinical Medical School, Lanzhou University-Nephrology Lanzhou Gansu Not Yet Recruiting
Huizhou Central People's Hospital-Endocrinology Huizhou Guangdong Not Yet Recruiting
The Second Affiliated Hospital of Shantou University Medical College-Nephrology Shantou Guangdong Not Yet Recruiting
The Second Hospital of Hebei Medical University-Nephrology Shijiazhuang Hebei Not Yet Recruiting
The People's Hospital of Anyang City/ TGE Center Hospital of Anyang City-Nephrology Anyang Henan Not Yet Recruiting
Yichang Central People's Hospital-Nephrology Yichang Hubei Not Yet Recruiting
The First Affiliated Hospital of Baotou Medical College-Nephrology Baotou Inner Mongolia Not Yet Recruiting
Changzhou No.2 People's Hospital-Nephrology Changzhou Jiangsu Not Yet Recruiting
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology Nanjing Jiangsu Not Yet Recruiting
The Affiliated Hospital of Jiangsu University-Endocrinology Zhenjiang Jiangsu Not Yet Recruiting
Pingxiang People's Hospital-Endocrinology Pingxiang Jiangxi Not Yet Recruiting
The Second Norman Bethune Hospital of Jilin University-Nephrology Changchun Jilin Not Yet Recruiting
Siping City Central People's Hospital-Nephrology Siping Jilin Not Yet Recruiting
Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital) -Nephrology Dalian Liaoning Not Yet Recruiting
Panjin Liaoyou Gemflower Hospital-Nephrology Panjin Liaoning Not Yet Recruiting
Qinghai Provincial People's Hospital-Endocrinology Xining Qinghai Not Yet Recruiting
Jinan Central Hospital-General Medicine Jinan Shandong Not Yet Recruiting
Shanghai General Hospital-Nephrology Shanghai Shanghai Municipality Not Yet Recruiting
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Nephrology Chengdu Sichuan Not Yet Recruiting
The Second People's Hospital of Yibin-Department of Nephrology Yibin Sichuan Not Yet Recruiting
Taizhou Hospital of Zhejiang Province-Nephrology Linhai Zhejiang Not Yet Recruiting
Ningbo No. 2 Hospital-Nephrology Ningbo Zhejiang Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07900438 on ClinicalTrials.gov ↗ ← All trials in China