Treatment of Patients With Diabetic Kidney Disease

NCT06187493 | Unknown

• 1 other identifier: diabetic kidney
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diabetic Kidney Disease

Keywords

Efficacy of ACEi versus SGLT2i

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

lisinopril, enalapril DRUG

1. 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. 2. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications. 3. 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.

Efficacy of ACEi

dapagliflozin, empagliflozin DRUG

1. 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. 2. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications. 3. 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.

Efficacy of SGLT2i

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that suffer from Diabetic kidney disease (DKD)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Lisinopril; Enalapril; dapagliflozin; empagliflozin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mohammed El-Tohamy, prof

  Assiut University

  STUDY DIRECTOR

• Walaa khalifa, prof

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ismael alaraby

CONTACT

+201007967808; drismael83@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Health Affairs Directorate

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 2, 2024
• Study Start: January 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 2, 2024

Record last verified: 2023-12