Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients.

Oman Ministry of Health

Status

Enrolling

Conditions

End Stage Chronic Renal Failure

Treatments

Drug: Dapagliflozin

Study type

Interventional

Funder types

Other

Identifiers

NCT07491042

67663

Details and patient eligibility

About

This project aims to examine the effects of six-month treatment with selective SGLT2 inhibitor dapagliflozin in patients with end-stage kidney disease on chronic peritoneal dialysis.

Methods: A prospective, open label, single-arm interventional clinical trial, will conduct at Nizwa Hospital from March 1st, 2026, to August 31th , 2026, and includes thirty (30) end-stage kidney disease diabetic and non-diabetic patients on chronic peritoneal dialysis, will receive selective SGLT2i Dapagliflozin 10 mg once daily (OD). Clinical and laboratory parameters will be assessed at baseline, then three and six months after drug initiation.

The primary outcomes are:1- change in ultrafiltration volume, 2- change in Kt/V (dialysis adequacy), 3. Change in the mean 24-hour urine volume.

Full description

Sodium-glucose cotransporter 2 inhibitors are glucose lowering agents by inhibition of SGLT2 in in the proximal tubule so SGLT2 inhibitors promote the renal excretion of glucose and thereby lower elevated blood glucose levels in patients with type 2 diabetes. This group of medication has proved protective effects on cardiovascular system and chronic kidney disease (CKD) in many studies, but the benefits of SGLT-2 inhibitors in patients with advanced CKD or on maintenance dialysis have not been included in these studies. Recent studies confirmed the expression of sodium-glucose cotransporter 2 (SGLT2) in the human peritoneum . So, by inhibition of this receptor's activity, SGLT2i can reduce the glucose absorption from peritoneal dialysis (PD) dialysate, subsequently increase the ultrafiltration in patients on PD, Animal studies demonstrated also that SGLT2 inhibitors can reduce peritoneal fibrosis and angiogenesis which contribute to ultrafiltration failure in a mouse model. In view of above, we hypothesized that SGLT2 inhibitors may increase ultrafiltration volume and improve long-term prognosis in patients undergoing peritoneal dialysis by alleviating volume overload and limiting peritoneal tissue damage.

This prospective observational study aims to examine the effects of six-month treatment with selective SGLT2 inhibitor dapagliflozin in patients with end-stage kidney disease (ESKD) on chronic peritoneal dialysis regardless of them being diabetic or not by reviewing the clinical and experimental data related to the renal effects of Dapagliflozin with a particular focus on the Peritoneal dialysis adequacy, ultrafiltration (UF), urine volume, blood glucose, and on certain inflammatory markers in these patients, with variable modalities of PD.

Enrollment

38 estimated patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

o age equal to or more than13 years.
- All genders.
- All patients undergoing chronic Peritoneal Dialysis.
- Urine output equal or more than 150 ml/24 hours.

Exclusion criteria

o Age less than 13 years
- Patients with type I diabetes mellitus.
- Patients with recurrent urinary tract infection (UTI) or peripheral vascular diseases (P.V.D).
- Patients with urine output less than 150 ml/24hours.
- Patients with recurrent hypoglycemic episodes
- Patients with acute or chronic liver disease,
- Patients who refuse to participate in the study.
- peritoneal Dialysis catheter (PDC) related peritonitis in last 3 months