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Clinical trials on the efficacy and safety of SGLT2-i in the treatment of proteinuria in renal transplant recipients

Clinical trials on the efficacy and safety of SGLT2-i in the treatment of proteinuria in renal transplant recipients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087630
Enrollment
Unknown
Registered
2024-07-31
Start date
2024-04-02
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

renal transplantion

Interventions

Kidney transplant patients with proteinuria receiving Dapagliflozin and no Dapagliflozin treatment group:none

Sponsors

Department of Nephrology, West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18; 2. First renal transplant, time from transplantation >= 3 months; 3. Standard immunosuppression consisted of a triple drug regimen including CNI, prednisolone and mycophenolate mofetil, receiving the maximum licensed dose of ACEi/ARB >= 4 weeks; 4. Patients who are routine visitors to the outpatient clinics for follow-ups at West China Hospital of Sichuan University; 5. Urinary albumin-to-creatinine ratio (UACR) between 30 mg/g and 5000 mg/g; 6. Stable renal function, with an eGFR >= 25 mL/min/1.73^2 and a decrease in eGFR <25% from baseline over the past 3 months.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes mellitus; 2. Preparation for pregnancy, pregnancy, or lactation,; 3. With malignant tumors or serious organ dysfunction; 4. History of recurrent or persistent hypotension, or shock; 5. Severe hypoglycemia within the past 3 months or have had episodes of unconsciousness due to hypoglycemia; 6. Recurrent urinary tract infections or genital infections within the past 6 months; 7. Severe peripheral vascular disease (i.e, history of amputation, gangrene, non-healing ulcers, ischemic rest pain); 8. NYHA class IV congestive heart failure at inclusion; 9. Urinary albumin-to-creatinine ratio (UACR) >5000 mg/g; 10. Renal artery stenosis in transplanted kidney; 11. Stroke, transient ischemic attack, myocardial infarction, or unstable angina within the 12 weeks; 12. With concomitant autoimmune diseases such as systemic lupus erythematosus or ANCA-associated vasculitis; 13. Abnormal liver function (AST or ALT > 3 times upper limit of normal; or total bilirubin > 2 times upper limit of normal); 14. Participation in other clinical trials; 15. Comorbidities with a prognosis of less than 2 years life expectancy.

Design outcomes

Primary

MeasureTime frame
Urinary albumin-to-creatinine ratio (UACR);urinary protein-to-creatinine ratio (PCR);24-hour urinary protein quantification;

Secondary

MeasureTime frame
serum creatinine;eGFR;qualitative urine protein test;Tacrolimus trough concentration;serum electrolytes;fasting blood glucose;lipid profile;urine glucose;

Countries

China

Contacts

Public ContactYunying Shi

West China Hospital, Sichuan University, Chengdu, Sichuan, China

yyshi0130@163.com+86 189 8060 5862

Outcome results

None listed

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