Effect of Dapagliflozin on Renal Outcomes and Bone Mineral Disease in Non-diabetic Chronic Kidney Disease Patients

NCT05735197 | Completed Phase 4

• 1 other identifier: MD.22.02.600
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

It is a randomized controlled trial in which 100 non diabetic chronic kidney disease (CKD) patient is being participated. Their estimated glomerular filtration rate (eGFR) between 25-75 ml/min/1.73 m2. Participants will be randomized into two groups:

• Study group: includes 50 patients, they will receive Sodium glucose co-transporter 2 inhibitor (SGLT2i) as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.
• Control group: includes 50 patients, they will receive placebo their medication. The investigators will follow up all patients for 12 months and compare their results. This study aims to:
• Assess SGLT2i role in delaying the progression of ongoing chronic kidney disease.
• Study the impact of SGLT2i on bone and mineral metabolism in this patients' population.

Conditions

Chronic Kidney Diseases; Bone Diseases, Metabolic

Keywords

CKD; Bone mineral disease; SGLT2i

Outcome Measures

Primary Outcomes (4)

• Effect of dapagliflozin on CKD progression

  effect of Dapagliflozin on eGFR (ml/min)

  1 year

• Effect of dapagliflozin on Bone

  effect on serum levels of bone turnover markers measured by ELISA

  1 year

• Effect of dapagliflozin on minerals

  effect of Dapagliflozin on calcium, phosphorus and magnesium

  1 year

• Effect of dapagliflozin on BMD

  assess Bone mineral disease (BMD) by using quantitative CT (QCT)

  1 year

Secondary Outcomes (1)

• Effect of dapagliflozin on blood pressure

  1 year

Study Arms (2)

Dapagliflozin group

ACTIVE COMPARATOR

Includes 50 patients, they will receive SGLT2i as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.

Drug: Dapagliflozin 10mg Tab

Placebo group

PLACEBO COMPARATOR

Includes 50 patients, they will receive placebo plus their medication.

Drug: Placebo

Interventions

Dapagliflozin 10mg Tab DRUG

Dapagliflozin which is (SGLT2 inhibitor) will be used as add on medication.

Also known as: Dapagliflozin

Dapagliflozin group

Placebo DRUG

Placebo which has the same shape as Dapagliflozin but without active ingredient will be used as add on medication for control group.

Also known as: control

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged more than 18 year.
• CKD patient with eGFR from 25 to 75 ml/min/1.73m2 with no evidence of acute drop of the GFR in the last 3 months.
• Willing to sign informed consent.

You may not qualify if:

• eGFR less than 25 ml/min per 1.73 m2.
• Medical history of chronic disease (diabetes mellitus, chronic liver and/or respiratory diseases).
• Patients with primary or secondary glomerulonephritis/ nephrotic syndrome (proteinuria ≥ 3.5 gm/day) and/or any evidence of active immunological/ collagen vascular disease.
• Inability to sign the study consent form or refusal to participate in the study.
• Evidence of urinary obstruction.
• Patients with evidence of volume depletion or receiving a combination of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBS)..
• Patients with current history of frequent hypotensive episodes or systolic blood pressure \<100 mmHg.
• Patients with history of recurrent urinary tract infection and/or valvovaginitis
• Patients with ongoing active malignancy.
• Patients with any evidence of active infection including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and tuberculosis (TB).
• Current or previous organ transplantation, or expected to get a kidney transplant within 12 months.
• Patients who received any SGLT2i for more than 3 months in the past.
• Patients who are already on medications that may affect or interact with bone metabolism such as bisphosphonates, calcitonin, steroid, denosumab and estrogen during the last 6 months.
• Pregnant and/or lactating woman.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology center, Mansoura University

Al Mansurah, Aldakahliya, 35511, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Bone Diseases, Metabolic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohamed Mohsen elshayeb, Msc

  Mansoura Urology and nephrology center, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology specialist at urology and nephrology center (principal investigator)

Model Details: 100 patients with non-diabetic CKD with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2 will be randomized into two groups: * Study group: includes 50 patients, they will receive SGLT2i as add on drug, Dapagliflozin 10 mg will be used once daily with or without food. * Control group: includes 50 patients, they will receive placebo plus their medication.

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 21, 2023
• Study Start: September 1, 2022
• Primary Completion: August 10, 2023
• Study Completion: November 1, 2023
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

EG (1)