The Effect of Dapagliflozin on Ultrafiltration Among Peritoneal Dialysis Patients

NCT04923295 | Completed

• 1 other identifier: SGLT2 PD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with average or high average peritoneal glucose transport status be included in the study as mentioned in the inclusion and exclusion criteria. The change in peritoneal glucose transport will be evaluated before and after one month treatment with 10 mg of Dapagliflozin. Peritoneal Equilibration Test (PET) test for patients before and after Dapagliflozin use and volume status of patients as measured by ultrafiltration from peritoneal dialysis exchanges. The aim of the trial is to determine whether dapagliflozin can decrease glucose absorption from peritoneal fluid and reduce plasma glucose absorption from the PD fluid and thus improve ultrafiltration with a reduction in intraperitoneal glucose exposure

Conditions

Peritoneal Dialysis Complication; Ultrafiltration Failure

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in the Mean Peritoneal Fluid Glucose ratio (D4/D0) after 4 Weeks of Treatment with 10 mg of Dapagliflozin

  The mean glucose concentrations will be evaluated by the modified Peritoneal Equilibrium Test from Baseline and after 4 weeks with Dapagliflozin treatment. The modified peritoneal equilibration test (PET) characterizes the peritoneal transport of fluid, creatinine and urea using a 4.5% dextrose peritoneal fluid.The concentration of glucose in the dialysis fluid (D4) at 4 hours is divided by the glucose in the dialysis fluid at the beginning (D0), generating the D4/D0.

  4 weeks

• Change from Baseline in the Mean Ultrafiltration Volume after 4 Weeks of Treatment with 10 mg of Dapagliflozin

  Ultrafiltration volume from Baseline and after 4 weeks with Dapagliflozin treatment assessment by the modified Peritoneal Equilibrium Test. The modified peritoneal equilibration test (PET) characterizes the peritoneal transport of fluid, creatinine and urea using a 4.5% dextrose peritoneal fluid.

  4 weeks

• Change from Baseline in the Mean 4 Hour Peritoneal Fluid to Plasma Creatinine (D/P) after 4 Weeks of Treatment with 10 mg of Dapagliflozin

  Peritoneal Solute Transport Rate is measured with 5% or greater reduction in PSTR as measured by the modified Peritoneal Equilibrium Test. The modified peritoneal equilibration test (PET) characterizes the peritoneal transport of fluid, creatinine and urea using a 4.5% dextrose peritoneal fluid.The concentration of creatinine in the dialysis fluid (D) at 4 hours is divided by the plasma creatinine (P), generating the D/P creatinine.

  4 weeks

• Change in Peritoneal Fluid Sodium Dip 4 Weeks of Treatment with 10 mg of Dapagliflozin

  Peritoneal Fluid sodium dip is done by measuring the peritoneal fluid sodium concentration at the time of infusion to the patient and after one hour of dwell time in the peritoneum.

  4 weeks

Secondary Outcomes (5)

• Response rate - 25 percent increase in the sodium dip at 60 minutes

  4 weeks

• Response rate - 25 percent increase in peritoneal fluid glucose D4/D0

  4 weeks

• Response rate - 10 percent or greater decrease in the mean 4 hour peritoneal fluid to plasma creatinine (D/P)

  4 weeks

• Response rate - 25 percent increase in ultrafiltration volume

  4 weeks

• Number of Participants With Treatment-Related Adverse Events as Assessed by (CTCAE v4.0) Common Terminology Criteria for Adverse Events Version 4.0

  6 weeks

Study Arms (1)

Pre Treatment and post treatment

EXPERIMENTAL

Patients on Peritoneal Dialysis will be evaluated by PET and transport status Patients on Peritoneal Dialysis will be evaluated by PET after treatment with Dapagliflozin

Drug: Dapagliflozin 10Mg Tab

Interventions

Dapagliflozin 10Mg Tab DRUG

Effect of Dapagliflozin on ultrafiltration and PET results among peritoneal dialysis patients

Also known as: Forxiga 10mgs

Pre Treatment and post treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The research targets patients on peritoneal dialysis with average and high transport status documented by Peritoneal Equilibrium Transport Test (PET test) in Najah National University Hospital.

You may not qualify if:

• Patients less than 18 years
• An episode of Peritonitis in less than three months
• History of recurrent hypoglycemia ( more than two episodes during one month prior to enrollment in the study)
• Liver disease: Hepatic impairment aspartate transaminase \[AST\] or alanine transaminase \[ALT\] \>3x the upper limit of normal \[ULN\]; or total bilirubin \>2x ULN at time of enrolment)
• Any allergic reaction to dapagliflozin
• Type I DM
• Pregnancy or women who are breast-feeding
• Symptomatic hypotension or a mean arterial pressure (MAP) less than 60 mmHg
• MI, unstable angina, stroke, or transient ischemic attack (TIA) within 12 weeks before enrolment
• Active malignancy requiring treatment at the time of visit -

Sponsors & Collaborators

• An-Najah National University: lead

Study Sites (1)

An Najah National University Hospital

Nablus, Palestinian Territories

Location

Related Publications (1)

• Hamdan Z, Abdel-Hafez Y, Enaya A, Sarsour A, Kharraz L, Nazzal Z. Dapagliflozin in peritoneal dialysis patients: a pilot study evaluating peritoneal membrane function. BMC Nephrol. 2024 Jan 26;25(1):37. doi: 10.1186/s12882-023-03429-2.

  PMID: 38279109 DERIVED

MeSH Terms

Interventions

dapagliflozin

Study Officials

• Zakaria I Hamdan, MD

  An Najah National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Pre and post intervention

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 11, 2021
• Study Start: June 2, 2021
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 4 weeks

Locations

PA (1)