Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT06187493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Patients With Diabetic Kidney Disease
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Efficacy of ACEi Versus SGLT2i in the Treatment of Patients With Diabetic Kidney Disease : Head to Head RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Due to irrespective of the limitations associated with estimated glomerular filtration rate (eGFR), it is crucial to develop new treatments that can effectively address these concerns. So, this study aimed to compare the effectiveness of SGlT2i versus ACEi in the progression of diabetic kidney disease including progression of albuminuria. Doubling of serum creatinine and need for renal replacement therapy
Detailed Description:
Diabetic kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) worldwide and continues to be the major contributor to kidney replacement therapy (KRT).
Despite the significant decline in diabetes-related complications in recent decades, the same trend cannot be observed in chronic kidney disease (CKD) patients due to DKD that requires KRT. Hence, there exists a significant requirement for novel treatment approaches that can enhance glycemic control while minimizing the risk of hypoglycemia, as well as reducing cardiovascular and renal risks within this population. Irrespective of the limitations associated with estimated glomerular filtration rate (eGFR), it is crucial to develop new treatments that can effectively address these concerns.
ACE inhibitors may delay the progression of nephropathy and reduce the risks of cardiovascular events in hypertensive patients with diabetes mellitus type I and type II.
SGLT2i have become the new standard of care for slowing CKD progression in patients with type 2 diabetes mellitus (T2DM, due to their specific renal and cardiovascular protective effects that are independent of the main metabolic and glucose-lowering effects.
Research questions:
Q1. Is there a significant effect of ACEi in treatment of patients with diabetic kidney disease.
Q2: Is there is a significant effect of SGLT2i in treatment of patients with diabetic kidney disease.
Q3: Which is more significantly efficient in treatment of patients with diabetic kidney disease (ACEi versus SGLT2i)
Despite the significant decline in diabetes-related complications in recent decades, the same trend cannot be observed in chronic kidney disease (CKD) patients due to DKD that requires KRT. Hence, there exists a significant requirement for novel treatment approaches that can enhance glycemic control while minimizing the risk of hypoglycemia, as well as reducing cardiovascular and renal risks within this population. Irrespective of the limitations associated with estimated glomerular filtration rate (eGFR), it is crucial to develop new treatments that can effectively address these concerns.
ACE inhibitors may delay the progression of nephropathy and reduce the risks of cardiovascular events in hypertensive patients with diabetes mellitus type I and type II.
SGLT2i have become the new standard of care for slowing CKD progression in patients with type 2 diabetes mellitus (T2DM, due to their specific renal and cardiovascular protective effects that are independent of the main metabolic and glucose-lowering effects.
Research questions:
Q1. Is there a significant effect of ACEi in treatment of patients with diabetic kidney disease.
Q2: Is there is a significant effect of SGLT2i in treatment of patients with diabetic kidney disease.
Q3: Which is more significantly efficient in treatment of patients with diabetic kidney disease (ACEi versus SGLT2i)
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: