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Efficacy and safety of canagliflozin in patients with type 2 diabetes and proteinuria after renal transplantation

Efficacy and safety of canagliflozin in patients with type 2 diabetes and proteinuria after renal transplantation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063658
Enrollment
Unknown
Registered
2022-09-14
Start date
2022-10-31
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Kidney transplant

Interventions

Test:Canagliflozin oral
Control:None

Sponsors

Renji Hospital affiliated to Shanghai Jiao Tong University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1: Patients more than 2 weeks after kidney transplantation 2: Years (range 18-70) for both men and women 3: Clinical diagnosis was type II diabetes. 4: The HbA1c at enrollment ranged from 6.5% to 10.5% 5: EGFR greater than 30 ml / min / 1.73m2 (determined using the CKD-EPI equation). 6: Urinary albumin to creatinine ratio (UACR) > 30mg / g. 7: Informed consent, and signed informed consents.

Exclusion criteria

Exclusion criteria: 1: Had a history of diabetic ketoacidosis or type 1 diabetes mellitus (T1DM). 2: Hereditary glucose galactose malabsorption or history of primary renal glucosuria. 3: Hyperkalaemia (serum potassium > 5.1mmol / L) 4: Uncontrolled hypertension (systolic blood pressure > 180 and / or diastolic blood pressure > 100 mmHg) 5: Prior history of myocardial infarction, prior history of heart failure 6: Abnormal liver function tests (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels > 2.0 times the upper limit of normal and total bilirubin > 1.5 times the ULN) and known significant liver diseases (e.g 7: The following drugs were used in combination: ACE and ARB use; Currently used SGLT2 inhibitors 8: Pregnant or breastfeeding, or planned pregnancy, or breastfeeding during the study period 9: Allergic to either component of SGLT2 (canagliflozin) 10: Those with evidence of active infection (respiratory, urinary, etc.) 11: Life expectancy less than 1 year 12: The use of drugs that interact with slgt2 class of drugs and are prone to induce adverse effects (rifampicin, carbamazepine, heparin, ritonavir, etc.) 13: Other conditions that, in the opinion of the investigator, were not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Scr;blood sugar;glycosylated hemoglobin;

Secondary

MeasureTime frame
BUN;ALT;AST;Ultrasound of transplanted kidneys;Urine protein;ACR;white blood cell;RBC count;HB;Incidence of urinary tract infections, hypoglycemia, electrolyte disturbances;

Countries

China

Contacts

Public ContactLi Dawei

Renji Hospital affiliated to Shanghai Jiao Tong University Medical College

15736875970@163.com15618069970

Outcome results

None listed

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