Nephrotic SyndromePhase 4NCT05966818
Effect of Dapagliflozin in Non-Diabetic Patients With Nephrotic Syndrome.
A Phase 4 study testing Dapagliflozin and Standard therapy (ACEI or ARB). and Standard Therapy (ACEI or ARB). in people with Nephrotic Syndrome, run by Ain Shams University.
Trial summary
Dapagliflozin is the first SGLT2 inhibitor to be approved for CKD treatment regardless of diabetes status. Since many etiologies of non-diabetic nephropathy are characterized by intraglomerular hypertension, it was hypothesized that dapagliflozin acutely decreases GFR and proteinuria in patients without diabetes at… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Dapagliflozin and Standard therapy (ACEI or ARB). and Standard Therapy (ACEI or ARB).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Mar 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18 and ≤60 years.
- Patients with diagnosis of nephrotic syndrome (proteinuria ≥3.5g/24hr, and serum albumin ≤30g/L) and Urine protein/Creatinine Ratio (UPCR) ≥2.
- Serum creatinine <3mg/dl (265.2umol/L) and eGFR >30 ml/min/1.73 m2.
- Pathological diagnosis with membranous nephropathy (MN) or focal segmental glomerulosclerosis (FSGS).
- Absence of any contraindication to dapagliflozin (eGFR less than 30).
- On a stable dose of an ACEI or ARB for at least 4 weeks prior to randomization or Initiation of ACEI or ARB.
- Agreed to participate and sign written informed consent.
Who cannot join
- Diagnosis of type 1 or type 2 diabetes mellitus.
- Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease or lupus nephritis.
- Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
- History of severe hypersensitivity or contraindications to dapagliflozin.
- History of repeated urinary tract infection or fungal infection.
- Patients with Hemodynamic instability or Hypotension.
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- Pregnancy or breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of the Renoprotective Effect of Dapagliflozin in Non-Diabetic Patients With Nephrotic Syndrome.
Dapagliflozin is the first SGLT2 inhibitor to be approved for CKD treatment regardless of diabetes status. Since many etiologies of non-diabetic nephropathy are characterized by intraglomerular hypertension, it was hypothesized that dapagliflozin acutely decreases GFR and proteinuria in patients without diabetes at risk of progressive kidney function loss such as nephrotic patients via a glucose independent hemodynamic mechanism.
The aim of the study is to assess the effect of Dapagliflozin on proteinuria and estimated glomerular filtration rate in non-diabetic patients with nephrotic syndrome in order to slow the decline in kidney function and the progression to ESRD and to prevent the complications of nephrotic syndrome like thrombotic diseases, peritonitis, hyperuricemia, and recurrent infections.
Read the detailed description
Nephrotic syndrome (NS) is a clinical syndrome defined by massive proteinuria (greater than 40 mg/m2 per hour) responsible for hypoalbuminemia (less than 30 g/L), with resulting hyperlipidemia, edema, and other complications as thrombotic diseases, peritonitis and recurrent infections.
Dapagliflozin is the first SGLT2 inhibitor to be approved for CKD treatment regardless of diabetes status. Since many etiologies of non-diabetic nephropathy are characterized by intra-glomerular hypertension, it was hypothesized that Dapagliflozin decreases GFR and proteinuria in patients without diabetes at risk of progressive kidney function loss via a glucose independent hemodynamic mechanism.
The aim of the study is to assess the effect of Dapagliflozin on proteinuria and estimated glomerular filtration rate in non-diabetic patients with nephrotic syndrome.
The study will include 90 patients with diagnosis of nephrotic syndrome (proteinuria ≥3.5g/24hr, and serum albumin ≤30g/L) and Urine protein/Creatinine Ratio (UPCR) ≥2. Serum creatinine <3mg/dl (265.2umol/L) and eGFR >30 ml/min/1.73 m2. They will assigned randomly into 2 groups. Each group will contain 45 patients.
- The first group will receive Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB).
- The second group will receive the standard therapy (ACEI or ARB).
- Baseline assessment:
At baseline , the non-diabetic patients with nephrotic syndrome will undergo:
- A detailed medical history,
- Physical examination,
- Blood pressure,
- Complete blood count (CBC),
- Baseline biochemical laboratory tests including: kidney function tests (Urinary protein/creatinine ratio (UPCR), eGFR, serum albumin, serum creatinine, serum uric acid, Blood urea nitrogen (BUN), lipid profile and serum glucose level
- Follow up assessment:
Patients will be followed up every four weeks during the study period (6 months) by measuring UPCR, eGFR, serum albumin, serum creatinine, Blood urea nitrogen (BUN), blood pressure, uric acid, glucose level, lipid profile and CBC. In between visits, patients will be contacted via phone for monitoring of any side effects.
- End of study assessment:
After 6 months, the previous biochemical tests will be performed such as UPCR, eGFR, serum albumin, serum creatinine, Blood urea nitrogen (BUN), blood pressure, uric acid, glucose level, lipid profile and CBC to measure changes from the baseline.
- Conditions
- Nephrotic Syndrome
- Being tested
- Dapagliflozin and Standard therapy (ACEI or ARB)., Standard Therapy (ACEI or ARB).
- Keywords
- Nephrotic Syndrome, SGLT2 inhibitor, dapagliflozin, management, proteinuria
- Medical subject headings
- Nephrotic Syndrome, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin and Standard therapy (ACEI or ARB).Drug
Also called Dapagliflozin (Diglifloz) 10 mg orally once daily and the standard therapy (ACEI or ARB).
Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB).
Standard Therapy (ACEI or ARB).Drug
Also called Standard Therapy which include either ACEI or ARB.
Standard Therapy which include either ACEI or ARB for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin group and Standard therapy which include either ACEI or ARB | Active comparator | - The first group (45 patients) will receive Dapagliflozin (Diglifloz) 10 mg orally once daily at any time of day with or without food. Tablets are to be swallowed whole with half a cup of water for 24 weeks and standard therapy which include either angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB). Receives: Drug: Dapagliflozin and Standard therapy (ACEI or ARB).; Drug: Standard Therapy (ACEI or ARB). |
| Standard therapy which include either ACEI or ARB | Active comparator | - The second group (45 patients); will receive the standard therapy (ACEI or ARB). Receives: Drug: Dapagliflozin and Standard therapy (ACEI or ARB).; Drug: Standard Therapy (ACEI or ARB). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the effect of Dapagliflozin on proteinuria.
By measuring UPCR.
Measured: Change from Baseline UPCR at 6 months
Assessment of the effect of Dapagliflozin on proteinuria.
By measuring serum albumin
Measured: Change from Baseline Serum Albumin at 6 months
Assessment of the effect of Dapagliflozin on Glomerular Filtration Rate (GFR).
By measuring serum creatinine.
Measured: Change from Baseline Serum Creatinine at 6 months
Assessment of the effect of Dapagliflozin on Glomerular Filtration Rate (GFR).
By measuring eGFR.
Measured: Change from Baseline eGFR at 6 months
Secondary outcomes (4)
Assessment of the effect of Dapagliflozin on Systolic blood pressure.
By measuring Systolic blood pressure.
Measured: Change from Baseline Systolic Blood Pressure at 6 months
Assessment of the effect of Dapagliflozin on Diastolic blood pressure.
By measuring Diastolic blood pressure.
Measured: Change from Baseline Diastolic Blood Pressure at 6 months
Assessment of the effect of Dapagliflozin on uric acid.
By measuring uric acid.
Measured: Change from Baseline Uric acid at 6 months
Assessment of the effect of Dapagliflozin on lipid profile.
By measuring lipid profile.
Measured: Change from Baseline lipid profile at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Model description
- The study is a Prospective, Randomized, Interventional, Parallel, Open Label study.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal A. Elkholy, Ain Shams University
- Investigators
- Nagwa A. Sabri, Professor, Study chair, Department of Clinical Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966818
- Sponsor's protocol ID
- Dapagliflozin in NS
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hussein N, Abdelrahman F, Khedr A, Aref H, Halawa MR, ELSharkawy M. Value of Sodium-Glucose Co-Transporter 2 Inhibitor Versus Traditional Medication in Microalbuminuric Diabetic Patients. Curr Diabetes Rev. 2021;17(6):e101120187809. doi: 10.2174/1573399816999201110194413.
PubMed 33176660Tapia C, Bashir K. Nephrotic Syndrome. 2023 May 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470444/
PubMed 29262216Wang CS, Greenbaum LA. Nephrotic Syndrome. Pediatr Clin North Am. 2019 Feb;66(1):73-85. doi: 10.1016/j.pcl.2018.08.006.
PubMed 30454752Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
PubMed 32970396
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Renoprotective Effect of Dapagliflozin in Non-Diabetic Patients With Nephrotic Syndrome.
- ClinicalTrials.gov ID
- NCT05966818
- Acronym / sponsor ID
- Dapagliflozin in NS
- Conditions
- Nephrotic Syndrome
- Keywords
- Nephrotic Syndrome, SGLT2 inhibitor, dapagliflozin, management, proteinuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 1 Aug 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.
Dapagliflozin is the first SGLT2 inhibitor to be approved for CKD treatment regardless of diabetes status. Since many etiologies of non-diabetic nephropathy are characterized by intraglomerular hypertension, it was hypothesized that dapagliflozin acutely decreases GFR and proteinuria in patients without diabetes at risk of progressive kidney function loss such as nephrotic patients via a glucose independent hemodynamic mechanism.
The aim of the study is to assess the effect of Dapagliflozin on proteinuria and estimated glomerular filtration rate in non-diabetic patients with nephrotic syndrome in order to slow the decline in kidney function and the progression to ESRD and to prevent the complications of nephrotic syndrome like thrombotic diseases, peritonitis, hyperuricemia, and recurrent infections.
Detailed description
Nephrotic syndrome (NS) is a clinical syndrome defined by massive proteinuria (greater than 40 mg/m2 per hour) responsible for hypoalbuminemia (less than 30 g/L), with resulting hyperlipidemia, edema, and other complications as thrombotic diseases, peritonitis and recurrent infections.
Dapagliflozin is the first SGLT2 inhibitor to be approved for CKD treatment regardless of diabetes status. Since many etiologies of non-diabetic nephropathy are characterized by intra-glomerular hypertension, it was hypothesized that Dapagliflozin decreases GFR and proteinuria in patients without diabetes at risk of progressive kidney function loss via a glucose independent hemodynamic mechanism.
The aim of the study is to assess the effect of Dapagliflozin on proteinuria and estimated glomerular filtration rate in non-diabetic patients with nephrotic syndrome.
The study will include 90 patients with diagnosis of nephrotic syndrome (proteinuria ≥3.5g/24hr, and serum albumin ≤30g/L) and Urine protein/Creatinine Ratio (UPCR) ≥2. Serum creatinine <3mg/dl (265.2umol/L) and eGFR >30 ml/min/1.73 m2. They will assigned randomly into 2 groups. Each group will contain 45 patients.
- The first group will receive Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB).
- The second group will receive the standard therapy (ACEI or ARB).
- Baseline assessment:
At baseline , the non-diabetic patients with nephrotic syndrome will undergo:
- A detailed medical history,
- Physical examination,
- Blood pressure,
- Complete blood count (CBC),
- Baseline biochemical laboratory tests including: kidney function tests (Urinary protein/creatinine ratio (UPCR), eGFR, serum albumin, serum creatinine, serum uric acid, Blood urea nitrogen (BUN), lipid profile and serum glucose level
- Follow up assessment:
Patients will be followed up every four weeks during the study period (6 months) by measuring UPCR, eGFR, serum albumin, serum creatinine, Blood urea nitrogen (BUN), blood pressure, uric acid, glucose level, lipid profile and CBC. In between visits, patients will be contacted via phone for monitoring of any side effects.
- End of study assessment:
After 6 months, the previous biochemical tests will be performed such as UPCR, eGFR, serum albumin, serum creatinine, Blood urea nitrogen (BUN), blood pressure, uric acid, glucose level, lipid profile and CBC to measure changes from the baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a Prospective, Randomized, Interventional, Parallel, Open Label study.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin group and Standard therapy which include either ACEI or ARB | Active comparator | Drug: Dapagliflozin and Standard therapy (ACEI or ARB)., Drug: Standard Therapy (ACEI or ARB).- The first group (45 patients) will receive Dapagliflozin (Diglifloz) 10 mg orally once daily at any time of day with or without food. Tablets are to be swallowed whole with half a cup of water for 24 weeks and standard therapy which include either angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB). |
| Standard therapy which include either ACEI or ARB | Active comparator | Drug: Dapagliflozin and Standard therapy (ACEI or ARB)., Drug: Standard Therapy (ACEI or ARB).- The second group (45 patients); will receive the standard therapy (ACEI or ARB). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age ≥18 and ≤60 years.
- Patients with diagnosis of nephrotic syndrome (proteinuria ≥3.5g/24hr, and serum albumin ≤30g/L) and Urine protein/Creatinine Ratio (UPCR) ≥2.
- Serum creatinine <3mg/dl (265.2umol/L) and eGFR >30 ml/min/1.73 m2.
- Pathological diagnosis with membranous nephropathy (MN) or focal segmental glomerulosclerosis (FSGS).
- Absence of any contraindication to dapagliflozin (eGFR less than 30).
Key exclusion criteria (8 listed)
- Diagnosis of type 1 or type 2 diabetes mellitus.
- Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease or lupus nephritis.
- Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
- History of severe hypersensitivity or contraindications to dapagliflozin.
- History of repeated urinary tract infection or fungal infection.
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 and Standard therapy (ACEI or ARB).Also: Dapagliflozin (Diglifloz) 10 mg orally once daily and the standard therapy (ACEI or ARB).Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB). | Drug | Dapagliflozin group and Standard therapy which include either ACEI or ARB, Standard therapy which include either ACEI or ARB |
| Standard Therapy (ACEI or ARB).Also: Standard Therapy which include either ACEI or ARB.Standard Therapy which include either ACEI or ARB for 24 weeks. | Drug | Dapagliflozin group and Standard therapy which include either ACEI or ARB, Standard therapy which include either ACEI or ARB |
Primary outcome
Assessment of the effect of Dapagliflozin on proteinuria.
Time frame: Change from Baseline UPCR at 6 months
By measuring UPCR.
Assessment of the effect of Dapagliflozin on proteinuria.
Time frame: Change from Baseline Serum Albumin at 6 months
By measuring serum albumin
Assessment of the effect of Dapagliflozin on Glomerular Filtration Rate (GFR).
Time frame: Change from Baseline Serum Creatinine at 6 months
By measuring serum creatinine.
Assessment of the effect of Dapagliflozin on Glomerular Filtration Rate (GFR).
Time frame: Change from Baseline eGFR at 6 months
By measuring eGFR.
4 secondary outcomes
Assessment of the effect of Dapagliflozin on Systolic blood pressure.
Time frame: Change from Baseline Systolic Blood Pressure at 6 months
Assessment of the effect of Dapagliflozin on Diastolic blood pressure.
Time frame: Change from Baseline Diastolic Blood Pressure at 6 months
Assessment of the effect of Dapagliflozin on uric acid.
Time frame: Change from Baseline Uric acid at 6 months
Assessment of the effect of Dapagliflozin on lipid profile.
Time frame: Change from Baseline lipid profile at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 33176660Hussein N, Abdelrahman F, Khedr A, Aref H, Halawa MR, ELSharkawy M. Value of Sodium-Glucose Co-Transporter 2 Inhibitor Versus Traditional Medication in Microalbuminuric Diabetic Patients. Curr Diabetes Rev. 2021;17(6):e101120187809. doi: 10.2174/1573399816999201110194413.
- Background: PubMed 29262216Tapia C, Bashir K. Nephrotic Syndrome. 2023 May 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470444/
- Background: PubMed 30454752Wang CS, Greenbaum LA. Nephrotic Syndrome. Pediatr Clin North Am. 2019 Feb;66(1):73-85. doi: 10.1016/j.pcl.2018.08.006.
- Background: PubMed 32970396Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
- Individual participant dataSharing planned: No
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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.
Nagwa A. Sabri, Professor study chair
Department of Clinical Pharmacy
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin and Standard therapy (ACEI or ARB). and Standard Therapy (ACEI or ARB). in people with Nephrotic Syndrome, run by Ain Shams University.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal A. Elkholy, PhD (+201060355448, amalanas9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the effect of Dapagliflozin on proteinuria. (time frame: Change from Baseline UPCR at 6 months). 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 NCT05966818, which also lists 4 linked publications.
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 1 Aug 2023.