Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13+
SponsorOman Ministry of Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Dapagliflozin

    Drug

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

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: selective SGLT2i Dapagliflozin and peritoneal dialysisExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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