Treatment of Patients With Diabetic Kidney Disease | NCT06187493 | Trialant

Treatment of Patients With Diabetic Kidney Disease | NCT06187493 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Efficacy of ACEi	Other	Patients receive an ACEi medication, such as lisinopril, enalapril, or ramipril. These drugs work by blocking the production of angiotensin II, a hormone that can constrict blood vessels and raise blood pressure.	Drug: lisinopril, enalapril
Efficacy of SGLT2i	Other	Patients receive an SGLT2i medication, such as dapagliflozin, empagliflozin, or canagliflozin. These drugs work by preventing the kidneys from reabsorbing glucose from the urine, leading to lower blood sugar levels and potentially reducing the risk of kidney damage.	Drug: dapagliflozin, empagliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lisinopril, enalapril	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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