Status:
UNKNOWN
Comparison Between the Efficacy of SGLT2 Inhibitor Therapy Versus ACE Inhibitor in the Treatment of Diabetic Kidney Disease
Lead Sponsor:
Omar Tarek Elfarargi
Conditions:
Diabetic Nephropathy Type 2
Eligibility:
All Genders
30-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Diabetes is the leading cause of chronic kidney disease (CKD) and end-stage kidney disease worldwide. Diabetic kidney disease (DKD) is a clinical diagnosis based upon the presence of reduced glomerula...
Detailed Description
The gap that could noticeably be found in the available literature is that the studies done on SGLT2i were almost tested on people who already using ACEi or ARBs, thus it is unclear whether SGLT2i is ...
Eligibility Criteria
Inclusion
- Men\& women with Type 2 Diabetic patient
- Age 30-65 years old
- UACR above 30mg/g
- eGFR between 30-90 ml/min/1.73m2
- Signed and dated informed consent
- Women must agree to use an effective birth control method if they are heterosexually active during the trial and should have a negative pregnancy test on day 1
Exclusion
- T1DM, History of diabetic ketoacidosis, beta-cell or pancreas transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Age below 30 and above 65 years old
- hyperkalemia (i.e., K above 6)
- ESRF\& e GFR less than 30 ml/min/1.73m2
- renal artery stenosis
- type2 DM pregnant woman \& gestational DM, breastfeeding
- history of prior amputation or high risk for amputation (including severe peripheral vascular disease, neuropathy, and diabetic foot ulcers)
- History of one or more severe hypoglycemic episodes within 6 months prior to screening Idiopathic or hereditary angioedema
- allergies, or intolerance to trial medications or their excipients
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT05373004
Start Date
March 1 2023
End Date
May 1 2024
Last Update
May 13 2022
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