Treatment of Patients With Diabetic Kidney Disease

Diabetic Kidney Disease Clinical Trial

Official title:

Efficacy of ACEi Versus SGLT2i in the Treatment of Patients With Diabetic Kidney Disease : Head to Head RCT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06187493
• Other study ID #: diabetic kidney
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: Ismael alaraby
• Phone: +201007967808
• Email: drismael83[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients that suffer from Diabetic kidney disease (DKD)

Exclusion Criteria:

• Genital mycotic infections

• Urosepsis and Pyelonephritis

• Lower limb amputation

• diabetic Ketoacidosis

• Euglycemic DKA

• Acute Kidney Injury

• Hypoglycemia

• Fournier Gangrene

• Hypersensitivity Reactions

• Bone fracture

• Bladder cancer

• Hyperkalemia

• Dyslipidemia

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• lisinopril, enalapril
Both arms should aim to achieve optimal blood pressure control, typically defined as a systolic blood pressure below 130 mmHg and a diastolic blood pressure below 80 mmHg. This can be achieved through lifestyle modifications, additional medications, or a combination of both. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications. Both arms may also receive other supportive care measures for DKD, such as protein restriction, dietary counseling, and management of other co-morbidities like anemia and hyperlipidemia.
• dapagliflozin, empagliflozin
Both arms should aim to achieve optimal blood pressure control, typically defined as a systolic blood pressure below 130 mmHg and a diastolic blood pressure below 80 mmHg. This can be achieved through lifestyle modifications, additional medications, or a combination of both. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications. Both arms may also receive other supportive care measures for DKD, such as protein restriction, dietary counseling, and management of other co-morbidities like anemia and hyperlipidemia.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention of the development of DKD and alter its natural progression.	Primary Outcome: Time to development of DKD: Measured as the time from randomization to the first occurrence of any of the following events: Sustained (=3 months) albumin-to-creatinine ratio (UACR) =300 mg/g End-stage kidney disease (ESKD) requiring dialysis or kidney transplantation; Measurement Tools: UACR: Measured in urine samples using commercial laboratory assays. eGFR: Estimated using creatinine levels and demographic data through formulas like CKD-EPI.; Cardiovascular events and mortality: Ascertained through medical records and national death registries.; Unit of Measure: Time to DKD development: Years or months Change in UACR: mg/g eGFR decline: mL/min/1.73 m² per year Cardiovascular events and mortality: Incidence per 70patient-years	baseline=3 months-year