Nephrotic SyndromePhase 4NCT06026787
Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Nephrotic Syndrome and Sodium-Glucose Transporter 2 Inhibitors, run by Ain Shams University at 1 site in Egypt.
Trial summary
Conducted as a randomized controlled clinical trial, this study aims to assess the potential benefits of incorporating dapagliflozin, an SGLT-2 inhibitor, into the treatment regimen of patients diagnosed with primary nephrotic syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotic Syndrome, Sodium-Glucose Transporter 2 Inhibitors
- What is being tested?
- Dapagliflozin 10mg Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Aug 2023
- Phase
- Phase 4
- 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
- eGFR > 25 mL/min/1.73m2
- Evidence of primary nephrotic syndrome by renal biopsy
- Non-diabetic kidney disease
Who cannot join
- Nephrotic syndrome secondary to lupus nephritis, AAV, amyloidosis, or secondary membranous nephropathy
- Hepatic impairment [AST or ALT >3 times ULN or total bilirubin >2 times the ULN] at the time of enrolment
- Pregnant or breast-feeding females
Trial locations and contacts
1 site in 1 country.
About this study
Conducted as a randomized controlled clinical trial, this study aims to assess the potential benefits of incorporating dapagliflozin, an SGLT-2 inhibitor, into the treatment regimen of patients diagnosed with primary nephrotic syndrome. The primary focus is on examining the impact of dapagliflozin on two key parameters: proteinuria and estimated glomerular filtration rate (eGFR).
The trial involves adult participants who have been definitively diagnosed with primary nephrotic syndrome through renal biopsy. In conjunction with their standard care, these participants will receive a daily dose of dapagliflozin at 10 mg. Over a span of six months, they will undergo comprehensive monthly assessments. These assessments will involve the collection and analysis of urine samples to quantify proteinuria and perform urinalysis. Additionally, blood samples will be taken to determine the estimated eGFR, lipid profile, glycated hemoglobin. Participants will also be encouraged to report any potential side effects resulting from their medication intake.
- Being tested
- Dapagliflozin 10mg Tab
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Dapagliflozin 10 mg will be added to the standard of care regimen of primary nephrotic syndrome patients
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin Arm | Experimental | During the study duration of 6 months, this cohort will be administered a daily dose of 10 mg dapagliflozin in conjunction with the standard of care for primary nephrotic syndrome based on the KDIGO 2021 guidelines. The conventional treatment regimen may encompass immunosuppressive medications, agents that block the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as deemed necessary. Receives: Drug: Dapagliflozin 10mg Tab |
| Control Arm | No intervention | This cohort will exclusively be subjected to the standard of care tailored for primary nephrotic syndrome. This could encompass administration of immunosuppressive drugs, agents targeting the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as warranted by individual needs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteinuria
Effect of dapagliflozin on proteinuria
Measured: 6 months
Estimated GFR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026787
- Sponsor's protocol ID
- MS 419/2023
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT06026787
- Acronym / sponsor ID
- MS 419/2023
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 7 Sep 2023 (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.
Conducted as a randomized controlled clinical trial, this study aims to assess the potential benefits of incorporating dapagliflozin, an SGLT-2 inhibitor, into the treatment regimen of patients diagnosed with primary nephrotic syndrome. The primary focus is on examining the impact of dapagliflozin on two key parameters: proteinuria and estimated glomerular filtration rate (eGFR).
The trial involves adult participants who have been definitively diagnosed with primary nephrotic syndrome through renal biopsy. In conjunction with their standard care, these participants will receive a daily dose of dapagliflozin at 10 mg. Over a span of six months, they will undergo comprehensive monthly assessments. These assessments will involve the collection and analysis of urine samples to quantify proteinuria and perform urinalysis. Additionally, blood samples will be taken to determine the estimated eGFR, lipid profile, glycated hemoglobin. Participants will also be encouraged to report any potential side effects resulting from their medication intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin Arm | Experimental | Drug: Dapagliflozin 10mg TabDuring the study duration of 6 months, this cohort will be administered a daily dose of 10 mg dapagliflozin in conjunction with the standard of care for primary nephrotic syndrome based on the KDIGO 2021 guidelines. The conventional treatment regimen may encompass immunosuppressive medications, agents that block the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as deemed necessary. |
| Control Arm | No intervention | –This cohort will exclusively be subjected to the standard of care tailored for primary nephrotic syndrome. This could encompass administration of immunosuppressive drugs, agents targeting the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as warranted by individual needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- eGFR > 25 mL/min/1.73m2
- Evidence of primary nephrotic syndrome by renal biopsy
- Non-diabetic kidney disease
Key exclusion criteria (3 listed)
- Nephrotic syndrome secondary to lupus nephritis, AAV, amyloidosis, or secondary membranous nephropathy
- Hepatic impairment [AST or ALT >3 times ULN or total bilirubin >2 times the ULN] at the time of enrolment
- Pregnant or breast-feeding females
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 TabDapagliflozin 10 mg will be added to the standard of care regimen of primary nephrotic syndrome patients | Drug | Dapagliflozin Arm |
Primary outcome
Proteinuria
Time frame: 6 months
Effect of dapagliflozin on proteinuria
Estimated GFR
Time frame: 6 months
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 7 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Nephrotic Syndrome and Sodium-Glucose Transporter 2 Inhibitors, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 3 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 7 Sep 2023. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proteinuria (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2023.