SGLT2 Inhibitors in Non-Diabetic CKD: Effects on Vascular Calcification and Anemia

Sponsor
Mansoura University
Study ID
NCT07344922
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (10Mg Tab) along with standard medical therapy — DRUG
    Participants will receive dapagliflozin 10 mg oral tablet once daily, with or without food, in addition to standard chronic kidney disease care. Treatment will continue for 12 months.
  • Placebo — OTHER
    Participants will receive a placebo oral tablet once daily, identical in appearance to dapagliflozin but containing no active drug, in addition to standard chronic kidney disease care. Treatment will continue for 12 months.

Study Details

The goal of this clinical trial is to learn if the drug dapagliflozin (an SGLT2 inhibitor) can help protect the kidneys, improve anemia, and support heart health in adults with chronic kidney disease (CKD) who do not have diabetes. The main questions it aims to answer are: Does dapagliflozin slow the worsening of kidney function compared to standard care? Does dapagliflozin improve anemia by increasing hemoglobin and related blood markers? Does dapagliflozin improve heart function and reduce cardiovascular problems in CKD patients? Researchers will compare dapagliflozin to a placebo (a look-alike pill with no active drug) to see if dapagliflozin works better than standard treatment alone. Participants will: Take dapagliflozin or a placebo once daily for 12 months, along with their usual CKD medications. Visit the clinic every 3 months for checkups, blood tests, urine tests, and heart evaluations. Have measurements of kidney function, anemia markers, and heart health taken at baseline and during follow-up visits.

Key Dates

Start date
Sep 1, 2022
Status verified
Jan 2026
Primary completion
Nov 1, 2023
Completion
Dec 1, 2023

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Participants receive dapagliflozin 10 mg once daily plus standard CKD care.
  • Placebo Comparator: Placebo
    Participants receive placebo once daily plus standard CKD care

Primary Outcome Measure

Time to first occurrence of sustained decline in kidney function or progression to end-stage kidney disease [ Time Frame: 12 months ]

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