Pharmacokinetic and Pharmacodynamic Properties of Dapagliflozin in patients with stage 4 chronic kidney disease

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100044600

Enrollment

Unknown

Registered

2021-03-24

Start date

2021-04-01

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

stage 4 chronic kidney disease

Interventions

single-dose group : single-dose of dapagliflozin 10mg

multi-dose group : dapagliflozin 10mg daily for 5 consecutive days

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Volunteer for this study and sign Informed Consent; 2. Aged 18-75 years,both male and female; 3. Patients with stage 4 chronic kidney disease, with or without type 2 diabetes; 4. Willing to take reliable contraception during the study.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes, Maturity-onset Diabetes of The Young or secondary diabetes, etc; 2. History of diabetic ketoacidosis; 3. Pegnancy or breastfeeding female; 4. Using non-dapagliflozin SGLT2i drugs, such as empagliflozin or canagliflozin and cannot adjust drugs; 5. Using dapagliflozin and cannot ajust to insulin for drug elution in the short term (one week); 6. Allergic or intolerance to SGLT2i drugs; 7. Used thiazolidinediones within the previous 6 months; 8. Requiring systemic treatment with glucocorticoids; 9. Hypotension (systolic blood pressure < 90mmHg or diastolic blood pressure < 60mmHg), postural hypotension; 10. Severe liver impairment; 11. Chronic cystitis, recurrent urinary tract infection, or other clinically active infections; 12. Bladder cancer, or any other tumor within 5 years; 13. History of clinically significant thyroid disease, acute cardiovascular and cerebrovascular diseases, tuberculosis and need anti-tuberculosis treatment (rifampicin); mental illness or other serious systemic diseases; 14. Participated in other drug clinical trials within the previous 3 months; 15. Patients with other clinically significant mental conditions, medical conditions or abnormal laboratory tests, which may not be suitable for the study judged by the investigator.

Design outcomes

Primary

Measure	Time frame
plasma concentration of dapagliflozin;plasma concentration of dapagliflozin-3-O-glucuronide Type ;	—

Secondary

Measure	Time frame
plasma glucose;24h urine glucose;	—

Countries

China

Contacts

Public ContactZhongyuan Xu

Nanfang Hospital of Soutnern Medical University

nfdangan@126.com+86 20 62787926

Outcome results

None listed

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