Skip to content

The effect of dapagliflozin on peritoneal fibrosis in peritoneal dialysis patients: a single center, prospective randomized controlled study

The effect of dapagliflozin on peritoneal fibrosis in peritoneal dialysis patients: a single center, prospective randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092824
Enrollment
Unknown
Registered
2024-11-25
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

End stage renal disease

Interventions

Treatment group:Conventional peritoneal dialysis+ dapagliflozin, orally, 1 capsule per time, once a day.
Control group:Conventional peritoneal dialysis

Sponsors

the First Affiliated Hospital of Anhui University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age range of 18-70 years old, male or female not limited; (2) Perform maintenance peritoneal dialysis treatment for more than 3 months; (3) 24 urine output = 400 ml/d; (4) Blood pressure = 120/70mm Hg.

Exclusion criteria

Exclusion criteria: (1) Type 1 diabetes patients; (2) Patients who develop peritonitis within 3 months; (3) Currently receiving SGLT2i treatment or within the past 3 months; (4) Patients with abnormal liver function: ALT or AST>3 times the upper limit of normal, total bilirubin>2 times the upper limit of normal; (5) Repeated severe hypoglycemic reactions (occurring more than twice within a month); (6) History of diabetes ketoacidosis; (7) Allergic to dapagliflozin; (8) Combined symptomatic urinary tract infections; (9) Patients with combined tumors and severe cachexia; (10) Women or lactating women.

Design outcomes

Primary

MeasureTime frame
24-hour urine output, peritoneal ultrafiltration volume, time and incidence of endpoint event (anuria) in patients;Residual kidney GFR;Peritoneum and residual kidney Kt/V;

Secondary

MeasureTime frame
Levels of transforming growth factor - ß (TGF - ß), connective tissue growth factor (CTGF), plasminogen activator inhibitor-1 (PAI-1), and a - smooth muscle actin (a - SMA) in peritoneal dialysis fluid;All-cause mortality, peritonitis, incidence of cardiovascular events, 24-hour average systolic blood pressure (mmHg) and mean diastolic blood pressure (mmHg), weight;

Countries

China

Contacts

Public ContactWang Yiping

the First Affiliated Hospital of Anhui University of Chinese Medicine

wypwyp54@aliyun.com+86 130 7558 0986

Outcome results

None listed

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