End Stage Chronic Renal FailureNCT07491042
Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients.
A study testing Dapagliflozin in people with End Stage Chronic Renal Failure, run by Oman Ministry of Health at 1 site in Oman.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- End Stage Chronic Renal Failure
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteOman
- Study dates
- 1 Apr 2026to 31 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oman1 site, 1 recruiting
- Recruiting
Jehad Badawi AL LAHAM
Nizwa
Jehad AL LAHAM, sarkosyr@gmail.com
Jehad B AL LAHAM, 94478719, jehad.laham@outlook.com
About this study
Official title: 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.
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.
- Conditions
- End Stage Chronic Renal Failure
- Being tested
- Dapagliflozin
- Keywords
- SGLT-2 inhibitor, Peritoneal Dialysis, urine volume
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called SGLT2i
study the effect of selective SGLT2i Dapagliflozin on peritoneal dialysis patients regarding UF/Kt/v and residual renal function
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in ultrafiltration volume in liter
Dapagliflozin improves the Ultrafiltration in patients on PD
Measured: 3 months
Secondary outcomes (1)
Follow-up of the blood glucose in millimole/L.
Usually Dapagliflozin improves the blood glucose
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Ministry of Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jehad Al Laham, Oman Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491042
- Sponsor's protocol ID
- 67663
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No