A Phase 4 interventional study of Dapagliflozin and Standard therapy (ACEI or ARB). and Standard Therapy (ACEI or ARB). in Nephrotic Syndrome, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
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.
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.
A. Baseline assessment:
At baseline , the non-diabetic patients with nephrotic syndrome will undergo:
B. 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.
C. 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.
191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
This study's planned enrollment of 90 is above the median of 46 across 122 interventional studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
- 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).
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).
Drug: Dapagliflozin and Standard therapy (ACEI or ARB). · Drug: Standard Therapy (ACEI or ARB).
Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB).
Also known as: Dapagliflozin (Diglifloz) 10 mg orally once daily and the standard therapy (ACEI or ARB).
Standard Therapy which include either ACEI or ARB for 24 weeks.
Also known as: Standard Therapy which include either ACEI or ARB.
Assessment of the effect of Dapagliflozin on proteinuria.
By measuring UPCR.
Time frame: Change from Baseline UPCR at 6 months
Assessment of the effect of Dapagliflozin on proteinuria.
By measuring serum albumin
Time frame: Change from Baseline Serum Albumin at 6 months
Assessment of the effect of Dapagliflozin on Glomerular Filtration Rate (GFR).
By measuring serum creatinine.
Time frame: Change from Baseline Serum Creatinine at 6 months
Assessment of the effect of Dapagliflozin on Glomerular Filtration Rate (GFR).
By measuring eGFR.
Time frame: Change from Baseline eGFR at 6 months
Assessment of the effect of Dapagliflozin on Systolic blood pressure.
By measuring Systolic blood pressure.
Time frame: Change from Baseline Systolic Blood Pressure at 6 months
Assessment of the effect of Dapagliflozin on Diastolic blood pressure.
By measuring Diastolic blood pressure.
Time frame: Change from Baseline Diastolic Blood Pressure at 6 months
Assessment of the effect of Dapagliflozin on uric acid.
By measuring uric acid.
Time frame: Change from Baseline Uric acid at 6 months
Assessment of the effect of Dapagliflozin on lipid profile.
By measuring lipid profile.
Time frame: Change from Baseline lipid profile at 6 months
No study locations are listed for this record.
Plan to share: No
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