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RecruitingNCT07491042Updated Mar 24, 2026

Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients.

An interventional study of Dapagliflozin in End Stage Chronic Renal Failure, sponsored by Oman Ministry of Health. Recruiting at 1 site in Oman. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Oman Ministry of Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
13 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • End Stage Chronic Renal Failure

Keywords

  • SGLT-2 inhibitor
  • Peritoneal Dialysis
  • urine volume
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's planned enrollment of 38 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Oman Ministry of Health is the lead sponsor of 18 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (estimated)

Study arms

  • 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

Interventions

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

    Also known as: SGLT2i

06

What researchers measure

Primary outcomes

  1. change in ultrafiltration volume in liter

    Dapagliflozin improves the Ultrafiltration in patients on PD

    Time frame: 3 months

Secondary outcomes

  1. Follow-up of the blood glucose in millimole/L.

    Usually Dapagliflozin improves the blood glucose

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07491042
Lead sponsor
Oman Ministry of Health
Responsible party
Jehad Al Laham (Principle Investigator, Oman Ministry of Health) — Principal investigator
First posted
Mar 24, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Mar 24, 2026

Study contacts

Jehad Badawi B AL LAHAM
Contact
sarkosyr@gmail.com
94478719
Jehad Badawi B AL LAHAM
Contact
jehad.laham@outlook.com
94478719

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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