NCT07491042

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

March 12, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 12, 2026

Last Update Submit

March 19, 2026

Conditions

Keywords

SGLT-2 inhibitorPeritoneal Dialysisurine volume

Outcome Measures

Primary Outcomes (1)

  • change in ultrafiltration volume in liter

    Dapagliflozin improves the Ultrafiltration in patients on PD

    3 months

Secondary Outcomes (1)

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

    3 months

Study Arms (1)

selective SGLT2i Dapagliflozin and peritoneal dialysis

EXPERIMENTAL

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
selective SGLT2i Dapagliflozin and peritoneal dialysis

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jehad Badawi AL LAHAM

Nizwá, Oman

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jehad Badawi B AL LAHAM

CONTACT

Jehad Badawi B AL LAHAM

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 24, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations