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A multicenter, randomized, parallel controlled, open-label study on the effects of SGLT2 inhibitor on the renal prognosis of patients with chronic kidney disease with type 2 diabetes

A multicenter, randomized, parallel controlled, open-label study on the effects of SGLT2 inhibitor on the renal prognosis of patients with chronic kidney disease with type 2 diabetes

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036769
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Diabetic Nephropathy

Interventions

SGLT2i group:SGLT2i (Dapagliflozin), 5mg qd p.o.
SGLT2i+GLP1-RA group:GLP-1RA (liraglutide), 18 mg/bottle, dosage: once a day, 0.6 mg each time, subcutaneous injection
if there are no obvious adverse reactions, increase to once a day, 1.2 mg each time, before breakfast in the second week Subcutaneous injection
plus dapagliflozin 5mg qd po
control group:Only use ACEI/ARB, CCB and other antihypertensive drugs, and other antihypertensive drugs

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age: >18 years old; 2. CKD3 stage: eGFR is 30~60ml/min*1.72m2; 3. Have used an appropriate dose of angiotensin converting enzyme inhibitor and angiotensin receptor inhibitor (RASi) for >= 8 weeks; 4. Kidney biopsy has been performed to confirm the pathological type; 5. Except for the CKD group, meet the diagnostic criteria for diabetes; 6. Has signed an informed consent form, is willing to comply with the research requirements, and regularly follow up in each center.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes; 2. Patients who have started taking SGLT2 inhibitors; 3. The subject has been diagnosed with heart failure, and there is a new cardiovascular and cerebrovascular event within 3M; 4. Unstable blood sugar control, diabetic ketoacidosis occurred in the past 3 months; 5. In patients with tumors, liver cirrhosis, etc., ALT and AST increased by 2 times or more from baseline; 6. Patients who used hormones, immunosuppressants, biological agents, and targeted drugs within 3 months before enrollment and after renal biopsy; 7. Secondary kidney disease caused by postrenal obstruction, immune-related and lymphoplasmic cell abnormalities; 8. Imaging confirmed as a single kidney or combined accessory renal artery.

Design outcomes

Primary

MeasureTime frame
serum creatinine;

Countries

China

Contacts

Public ContactZhangWen

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

jmd1211@163.com+86 13801725429

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026