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Safety and efficacy of proline henggliflozin tablets in patients with diabetes after renal transplantation

Safety and efficacy of proline henggliflozin tablets in patients with diabetes after renal transplantation

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096542
Enrollment
Unknown
Registered
2025-01-26
Start date
2025-02-08
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Post-transplant diabetes

Interventions

Application of Proline Henggliflozin Tablets:NA

Sponsors

The Eighth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for PTDM or type 2 diabetes. 2. Age 18-75 years old. 3. Time after kidney transplantation >= 1 year and = 45 ml/min calculated according to the CKD-EPI formula.

Exclusion criteria

Exclusion criteria: 1. Repeated transplantation within 1 year after transplantation. 2. Concurrent infection, history of recurrent urinary tract infection. 3. Uncorrected acute complications of diabetes. 4. Concurrent rejection of renal transplantation. 5. Infectious diseases or other diseases that persistently affect renal function. 6. Malnutrition. 7. Participants with known allergies to SGLT2 inhibitors or any excipients of the product. 8. Pregnant or lactating women. 9. Patients with moderate and severe hepatic impairment (Child-Pugh B and C).

Design outcomes

Primary

MeasureTime frame
time in range on CGM;fasting blood glucose;postloading blood glucose;HbA1c;

Secondary

MeasureTime frame
UACR;serum UA;blood pressure;Heart rate;weight;BMI;total insulin dose ;Cardiovascular disease incidence;Graft survival rate;all-cause mortality;

Countries

China

Contacts

Public ContactJing Shen

The Eighth Medical Center of PLA General Hospital

shenjingshenhua@126.com+86 135 2257 8170

Outcome results

None listed

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