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

NCT05966818 | Unknown Phase 4

• 1 other identifier: Dapagliflozin in NS
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Nephrotic Syndrome

Keywords

Nephrotic Syndrome; SGLT2 inhibitor; dapagliflozin; management; proteinuria

Outcome Measures

Primary Outcomes (4)

• Assessment of the effect of Dapagliflozin on proteinuria.

  By measuring UPCR.

  Change from Baseline UPCR at 6 months

• Assessment of the effect of Dapagliflozin on proteinuria.

  By measuring serum albumin

  Change from Baseline Serum Albumin at 6 months

• Assessment of the effect of Dapagliflozin on Glomerular Filtration Rate (GFR).

  By measuring serum creatinine.

  Change from Baseline Serum Creatinine at 6 months

• Assessment of the effect of Dapagliflozin on Glomerular Filtration Rate (GFR).

  By measuring eGFR.

  Change from Baseline eGFR at 6 months

Secondary Outcomes (4)

• Assessment of the effect of Dapagliflozin on Systolic blood pressure.

  Change from Baseline Systolic Blood Pressure at 6 months

• Assessment of the effect of Dapagliflozin on Diastolic blood pressure.

  Change from Baseline Diastolic Blood Pressure at 6 months

• Assessment of the effect of Dapagliflozin on uric acid.

  Change from Baseline Uric acid at 6 months

• Assessment of the effect of Dapagliflozin on lipid profile.

  Change from Baseline lipid profile at 6 months

Study Arms (2)

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).

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).

Drug: Dapagliflozin and Standard therapy (ACEI or ARB).; Drug: Standard Therapy (ACEI or ARB).

Interventions

Dapagliflozin and Standard therapy (ACEI or ARB). DRUG

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).

Dapagliflozin group and Standard therapy which include either ACEI or ARB; Standard therapy which include either ACEI or ARB

Standard Therapy (ACEI or ARB). DRUG

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

Also known as: Standard Therapy which include either ACEI or ARB.

Dapagliflozin group and Standard therapy which include either ACEI or ARB; Standard therapy which include either ACEI or ARB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (4)

• 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.

  PMID: 33176660 BACKGROUND

• Tapia C, Bashir K. Nephrotic Syndrome. 2023 May 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470444/

  PMID: 29262216 BACKGROUND

• Wang CS, Greenbaum LA. Nephrotic Syndrome. Pediatr Clin North Am. 2019 Feb;66(1):73-85. doi: 10.1016/j.pcl.2018.08.006.

  PMID: 30454752 BACKGROUND

• Heerspink 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.

  PMID: 32970396 BACKGROUND

MeSH Terms

Conditions

Nephrotic Syndrome; Proteinuria

Interventions

dapagliflozin; Standard of Care; Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Nagwa A. Sabri, Professor

  Department of Clinical Pharmacy

  STUDY CHAIR

Central Study Contacts

Amal A. Elkholy, PhD

CONTACT

+201060355448; amalanas9@gmail.com

Reem G. Hammad, Master's

CONTACT

+201019934446; reem.gamal19939@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

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

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: August 1, 2023
• Study Start: August 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share