Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-01 @ 8:49 AM
Study NCT ID:
NCT04923295
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2021-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dapagliflozin on Ultrafiltration Among Peritoneal Dialysis Patients
Sponsor:
An-Najah National University
Organization:
Study Overview
Official Title:
The Effect of Dapagliflozin on Ultrafiltration Among Peritoneal Dialysis Patients
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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.
Research participants will be recruited from the patients on peritoneal dialysis in NNUH. A study team member will prescreen the patient based upon the inclusion/exclusion criteria. If potentially eligible, the coordinator will approach candidates directly to provide information about the study and to invite them to voluntarily participate. The primary investigator will provide the participant with the informed consent document to read to read and to sign it if they agree to participate. The study includes patients on peritoneal dialysis with average and high transport status documented by Peritoneal Equilibrium Transport Test (PET test).
Prior to starting treatment with Dapagliflozin all patients included in the study population will have the following tests performed:
Modified Peritoneal Equilibrium Test with 4.5% Dextrose peritoneal fluid Hemoglobin A1C levels 24 urine collection for protein, glucose, and creatine clearance Peritoneal fluid albumin levels Patients will report daily ultrafiltration volumes one week prior to the start of treatment Blood pressure, heart rate and weight of patients prior to the start of treatment Sodium sieving will estimated by subtracting the sodium dialysate concentration at time zero from the sodium dialysate concentration at one hour. Uric Acid levels
Patients will then start on Dapagliflozin 10 mg daily for 4 weeks. During the study period patients will be evaluated for any side effects including;
Volume Depletion Ketoacidosis Hypoglycemia Urinary Tract infections Uric Acid levels Discontinuation of drug due to Adverse Events (DAEs) Changes in clinical chemistry/hematology parameters Adverse events of interest (volume depletion, major hypoglycemic events, fractures, diabetic ketoacidosis, genital and urinary tract infections)
Patients will monitored for the following:
Glucose levels Bicarbonate levels Blood pressure readings Hemoglobin A1C levels every 4 months.
Depending on the volume of ultrafiltration per patient and patient's weight, the investigators will have the choice to change the prescription; as per the investigator clinical judgment. For example if a patient with a four PD exchanges using 2.5% dextrose which yielded about 1.5L of ultrafiltration daily, and once started on Dapagliflozin had an increase ultrafiltration of 2.3 L a day, the investigator will be able to adjust the prescription to include 1.5% exchanges; resulting in less ultrafiltration volume.
At the end of the study period patient will be evaluated for the following:
Modified Peritoneal Equilibrium Test with 4.5% Dextrose peritoneal fluid 24 urine collection for protein, glucose, and creatine clearance Peritoneal fluid albumin levels Blood pressure, heart rate and weight of patients prior to the start of treatment Sodium sieving will estimated by subtracting the sodium dialysate concentration at time zero from the sodium dialysate concentration at one hour. Uric acid levels The collection of all blood pressure, hear rate reading and weights of patients will be recorded along with a daily ultrafiltration volume.
Samples of serum and peritoneal fluid effluent will be frozen -20C for any future studies.
Research participants will be recruited from the patients on peritoneal dialysis in NNUH. A study team member will prescreen the patient based upon the inclusion/exclusion criteria. If potentially eligible, the coordinator will approach candidates directly to provide information about the study and to invite them to voluntarily participate. The primary investigator will provide the participant with the informed consent document to read to read and to sign it if they agree to participate. The study includes patients on peritoneal dialysis with average and high transport status documented by Peritoneal Equilibrium Transport Test (PET test).
Prior to starting treatment with Dapagliflozin all patients included in the study population will have the following tests performed:
Modified Peritoneal Equilibrium Test with 4.5% Dextrose peritoneal fluid Hemoglobin A1C levels 24 urine collection for protein, glucose, and creatine clearance Peritoneal fluid albumin levels Patients will report daily ultrafiltration volumes one week prior to the start of treatment Blood pressure, heart rate and weight of patients prior to the start of treatment Sodium sieving will estimated by subtracting the sodium dialysate concentration at time zero from the sodium dialysate concentration at one hour. Uric Acid levels
Patients will then start on Dapagliflozin 10 mg daily for 4 weeks. During the study period patients will be evaluated for any side effects including;
Volume Depletion Ketoacidosis Hypoglycemia Urinary Tract infections Uric Acid levels Discontinuation of drug due to Adverse Events (DAEs) Changes in clinical chemistry/hematology parameters Adverse events of interest (volume depletion, major hypoglycemic events, fractures, diabetic ketoacidosis, genital and urinary tract infections)
Patients will monitored for the following:
Glucose levels Bicarbonate levels Blood pressure readings Hemoglobin A1C levels every 4 months.
Depending on the volume of ultrafiltration per patient and patient's weight, the investigators will have the choice to change the prescription; as per the investigator clinical judgment. For example if a patient with a four PD exchanges using 2.5% dextrose which yielded about 1.5L of ultrafiltration daily, and once started on Dapagliflozin had an increase ultrafiltration of 2.3 L a day, the investigator will be able to adjust the prescription to include 1.5% exchanges; resulting in less ultrafiltration volume.
At the end of the study period patient will be evaluated for the following:
Modified Peritoneal Equilibrium Test with 4.5% Dextrose peritoneal fluid 24 urine collection for protein, glucose, and creatine clearance Peritoneal fluid albumin levels Blood pressure, heart rate and weight of patients prior to the start of treatment Sodium sieving will estimated by subtracting the sodium dialysate concentration at time zero from the sodium dialysate concentration at one hour. Uric acid levels The collection of all blood pressure, hear rate reading and weights of patients will be recorded along with a daily ultrafiltration volume.
Samples of serum and peritoneal fluid effluent will be frozen -20C for any future studies.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: