Treatment of Patients With Diabetic Kidney Disease

December 28, 2023 updated by: Ismael ahmed amin mohammed alaraby, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Efficacy of ACEi
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
  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.
Other: Efficacy of SGLT2i
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
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevention of the development of DKD and alter its natural progression.
Time Frame: baseline≥3 months-year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mohammed El-Tohamy, prof, Assiut University
  • Study Director: Walaa khalifa, prof, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Estimated)

January 1, 2024

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diabetic kidney

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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