Effect of Dapagliflozin in Non-Diabetic Patients With Nephrotic Syndrome.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome

NCT06026787

Nephrotic Syndrome Sodium-Glucose Transporter 2 Inhibitors

COMPLETED PHASE4

SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome

NCT07214818

Nephrotic Syndrome

ACTIVE_NOT_RECRUITING PHASE2/PHASE3

Empagliflozin in Patients With Glomerulonephritis

NCT05283057

Glomerulonephritis Proteinuria

COMPLETED PHASE3

Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney Disease

NCT06982079

Chronic Kidney Disease Stage 5 CKD Stage 4

RECRUITING PHASE3

Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients

NCT06897605

Chronic Kidney Disease(CKD) Anemia, Kidney Disease, Chronic

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

A. 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

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nephrotic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a Prospective, Randomized, Interventional, Parallel, Open Label study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

90 opaque envelopes will be numbered serially and the corresponding letter which denotes the allocation will be put according to the electronic randomization table. Then all envelopes will be closed and put in one box. When the first patient arrives, the envelope will be opened and the patient will be allocated according to the letter inside.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dapagliflozin group and Standard therapy which include either 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).

Group Type ACTIVE_COMPARATOR

Dapagliflozin and Standard therapy (ACEI or ARB).

Intervention Type DRUG

Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB).

Standard Therapy (ACEI or ARB).

Intervention Type DRUG

Standard Therapy which include either ACEI or ARB for 24 weeks.

Standard therapy which include either ACEI or ARB

\- The second group (45 patients); will receive the standard therapy (ACEI or ARB).

Group Type ACTIVE_COMPARATOR

Dapagliflozin and Standard therapy (ACEI or ARB).

Intervention Type DRUG

Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB).

Standard Therapy (ACEI or ARB).

Intervention Type DRUG

Standard Therapy which include either ACEI or ARB for 24 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapagliflozin and Standard therapy (ACEI or ARB).

Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB).

Intervention Type DRUG

Standard Therapy (ACEI or ARB).

Standard Therapy which include either ACEI or ARB for 24 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dapagliflozin (Diglifloz) 10 mg orally once daily and the standard therapy (ACEI or ARB). Standard Therapy which include either ACEI or ARB.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No