Dapagliflozin for people on chronic peritoneal dialysis
Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients: A Six-month Prospective .Study
NA · Oman Ministry of Health · NCT07491042
This will give dapagliflozin 10 mg once daily for six months to people with end-stage kidney disease on chronic peritoneal dialysis to see if it increases fluid removal and urine output.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | Oman Ministry of Health (other gov) |
| Locations | 1 site (Nizwa) |
| Trial ID | NCT07491042 on ClinicalTrials.gov |
What this trial studies
A prospective, open-label, single-arm trial at Nizwa Hospital will enroll 30 patients aged 13 and older with end-stage kidney disease on chronic peritoneal dialysis, including both diabetic and non-diabetic participants. All participants will receive dapagliflozin 10 mg once daily and undergo clinical and laboratory assessments at baseline, three months, and six months. Primary outcomes are change in peritoneal ultrafiltration volume, dialysis adequacy (Kt/V), and mean 24-hour urine volume. The study runs from March 1 to August 31, 2026, and excludes patients with type 1 diabetes, low urine output (<150 ml/24h), recent peritonitis, recurrent UTI, peripheral vascular disease, or significant liver disease.
Who should consider this trial
Good fit: People aged 13 or older on chronic peritoneal dialysis with urine output ≥150 ml/24h, including diabetic and non-diabetic patients who do not have type 1 diabetes or recent peritonitis, are ideal candidates.
Not a fit: Patients with urine output under 150 ml/24h, type 1 diabetes, recent PD-catheter peritonitis, recurrent UTI, peripheral vascular disease, significant liver disease, or those on hemodialysis are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, dapagliflozin could increase peritoneal ultrafiltration and urine output, improving volume control and dialysis adequacy for people on PD.
How similar studies have performed: SGLT2 inhibitors have shown kidney and cardiovascular benefits in earlier CKD trials and animal studies indicate possible peritoneal effects, but use in peritoneal dialysis patients is novel with only limited mechanistic or small-scale data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nizwa
- Jehad Badawi AL LAHAM — Nizwa, Oman (RECRUITING)
Study contacts
- Study coordinator: Jehad Badawi B AL LAHAM
- Email: sarkosyr@gmail.com
- Phone: 94478719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: End Stage Chronic Renal Failure, SGLT-2 inhibitor, Peritoneal Dialysis, urine volume