Peritoneal Dialysis ComplicationNCT04923295
The Effect of Dapagliflozin on Ultrafiltration Among Peritoneal Dialysis Patients
A study testing Dapagliflozin 10Mg Tab in people with Peritoneal Dialysis Complication and Ultrafiltration Failure, run by An-Najah National University at 1 site in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis Complication, Ultrafiltration Failure
- What is being tested?
- Dapagliflozin 10Mg Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 2 Jun 2021to 28 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
An Najah National University Hospital
Nablus
About this study
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.
Read more
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
Read the 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.
- Being tested
- Dapagliflozin 10Mg Tab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10Mg TabDrug
Also called Forxiga 10mgs
Effect of Dapagliflozin on ultrafiltration and PET results among peritoneal dialysis patients
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dapagliflozin 10Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (5)
Response rate - 25 percent increase in the sodium dip at 60 minutes
The response rate was defined as the number of participants with a 25% or greater increase in in the sodium dip at 60 minutes from baseline and after 4 weeks of treatment with 10 mg of Dapagliflozin
Measured: 4 weeks
Response rate - 25 percent increase in peritoneal fluid glucose D4/D0
The response rate was defined as the number of participants with a 25% or greater increase in D4/D0 peritoneal fluid glucose concentration from baseline and after 4 weeks of treatment with 10 mg of Dapagliflozin
Measured: 4 weeks
Response rate - 10 percent or greater decrease in the mean 4 hour peritoneal fluid to plasma creatinine (D/P)
The response rate was defined as the number of participants with a 10% or greater decrease in D4/D0 peritoneal fluid glucose concentration from baseline and after 4 weeks of treatment with 10 mg of Dapagliflozin
Measured: 4 weeks
Response rate - 25 percent increase in ultrafiltration volume
The response rate was defined as the number of participants with a 25% or greater increase in ultrafiltration volume from baseline and after 4 weeks of treatment with 10 mg of Dapagliflozin
Measured: 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
The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start2 Jun 2021
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal Dialysis ComplicationStudies 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
- Model description
- Pre and post intervention
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- An-Najah National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zakaria Hamdan, An-Najah National University
- Investigators
- Zakaria I Hamdan, MD, Principal investigator, An Najah National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923295
- Sponsor's protocol ID
- SGLT2 PD
- Status last verified
- Oct 2022
- First submitted
- 25 May 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 38279109
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dapagliflozin on Ultrafiltration Among Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT04923295
- Acronym / sponsor ID
- SGLT2 PD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- An-Najah National UniversityUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre and post intervention
| Arm | Type | Receives |
|---|---|---|
| Pre Treatment and post treatment | Experimental | Drug: Dapagliflozin 10Mg TabPatients on Peritoneal Dialysis will be evaluated by PET and transport status Patients on Peritoneal Dialysis will be evaluated by PET after treatment with Dapagliflozin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10Mg TabAlso: Forxiga 10mgsEffect of Dapagliflozin on ultrafiltration and PET results among peritoneal dialysis patients | Drug | Pre Treatment and post treatment |
Primary outcome
Change from Baseline in the Mean Peritoneal Fluid Glucose ratio (D4/D0) after 4 Weeks of Treatment with 10 mg of Dapagliflozin
Time frame: 4 weeks
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.
Change from Baseline in the Mean Ultrafiltration Volume after 4 Weeks of Treatment with 10 mg of Dapagliflozin
Time frame: 4 weeks
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.
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
Time frame: 4 weeks
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.
Change in Peritoneal Fluid Sodium Dip 4 Weeks of Treatment with 10 mg of Dapagliflozin
Time frame: 4 weeks
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.
5 secondary outcomes
Response rate - 25 percent increase in the sodium dip at 60 minutes
Time frame: 4 weeks
Response rate - 25 percent increase in peritoneal fluid glucose D4/D0
Time frame: 4 weeks
Response rate - 10 percent or greater decrease in the mean 4 hour peritoneal fluid to plasma creatinine (D/P)
Time frame: 4 weeks
Response rate - 25 percent increase in ultrafiltration volume
Time frame: 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
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Derived from this study: PubMed 38279109Hamdan 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zakaria I Hamdan, MD principal investigator
An Najah National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin 10Mg Tab in people with Peritoneal Dialysis Complication and Ultrafiltration Failure, run by An-Najah National University at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Mean Peritoneal Fluid Glucose ratio (D4/D0) after 4 Weeks of Treatment with 10 mg of Dapagliflozin (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.