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Pharmacokinetic and safety of Henagliflozin in diabetes patients on dialysis

Pharmacokinetic and safety of Henagliflozin in diabetes patients on dialysis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062872
Enrollment
Unknown
Registered
2022-08-22
Start date
2022-08-22
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

diabetes and dialysis

Interventions

HD5:Henagliflozin 5 mg qd+HD
HD10:Henagliflozin 10 mg qd+HD
PD5:Henagliflozin 5 mg qd+PD
PD10:Henagliflozin 10 mg qd+PD

Sponsors

Renji Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Understand the present study, and agree and sign informed consent; 2. Aged 18-75 years at the screening; 3. Hemodialysis three times/week and regular hemodialysis>= 3 month; 4. Kt/V of single dialysis was more than 1.0 or URR more than 60% in 3 month; 5. CAPD or DAPD patients, more than 3 month; 6. Kt/V more than 1.7 in 6 month for PD patients; 7. Type 2 Diabetes.

Exclusion criteria

Exclusion criteria: 1. Hypocaemia events more than 2 times in 4 weeks; 2. Hb lower than 7 g/dL or more than 14 g/dL; 3. BPC lower than 5x10^9/L; 4. Liver function (ALT or AST) is three times the upper the normal; 5. Patients with active infectious disease; 6. Patients with cancer; 7. Patients with ketoacidosis in 3 month; 8. Patients with genitourinary system infection; 9. Allergy for henagliflozin; 10. Pregnant and lactating women; 11. Participating in other intervention studies; 12. The investigator judged that the condition of the subjects was not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Henagliflozin concentration;

Secondary

MeasureTime frame
events of hypocaemia and ketoacidosis;

Countries

China

Contacts

Public ContactLeyi Gu

Renji Hospital, Shanghai Jiaotong University School of Medicine

guleyi@aliyun.com+86 13918148433

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026