Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients.

March 19, 2026 updated by: Jehad Al Laham, Oman Ministry of Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: selective SGLT2i Dapagliflozin and peritoneal dialysis
it is clinical trial on drug Dapagliflozin and its effect on peritoneal dialysis: UF, Kt/V, and residual renal function, No of patients is 38
Drug: Dapagliflozin
study the effect of selective SGLT2i Dapagliflozin on peritoneal dialysis patients regarding UF/Kt/v and residual renal function
Other Names:
  • SGLT2i

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in ultrafiltration volume in liter
Time Frame: 3 months
Dapagliflozin improves the Ultrafiltration in patients on PD
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up of the blood glucose in millimole/L.
Time Frame: 3 months
Usually Dapagliflozin improves the blood glucose
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oman Ministry of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67663

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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