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Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients.

Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients: A Six-month Prospective .Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07491042
Enrollment
38
Registered
2026-03-24
Start date
2026-04-01
Completion date
2027-01-31
Last updated
2026-03-24

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

Conditions

End Stage Chronic Renal Failure

Keywords

SGLT-2 inhibitor, Peritoneal Dialysis, urine volume

Brief summary

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.

Detailed 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.

Interventions

DRUGDapagliflozin

study the effect of selective SGLT2i Dapagliflozin on peritoneal dialysis patients regarding UF/Kt/v and residual renal function

Sponsors

Oman Ministry of Health
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in ultrafiltration volume in liter3 monthsDapagliflozin improves the Ultrafiltration in patients on PD

Secondary

MeasureTime frameDescription
Follow-up of the blood glucose in millimole/L.3 monthsUsually Dapagliflozin improves the blood glucose

Countries

Oman

Contacts

CONTACTJehad Badawi B AL LAHAM
sarkosyr@gmail.com94478719

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026