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NCT Number: NCT04918407

Effects of Empagliflozin in Reducing Oxidative Stress After Kidney Transplantation

The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes after kidney transplantation. The association is examined by comparing the difference in oxidative modifications before and after 90 days treatment with 25 mg empagliflozin plus insulin compared to insulin treatment. The study is randomised and double-blinded. Each treatment group consists of 20 patients. Oxidative stress markers are measured by serum level of superoxide dismutase activity ,lipid peroxidation assay kit, glutathione assay, glutathione peroxidase activity , total antioxidant capacity assay oxidant status , carbonyl content assay and bca protein assay . . A student t-test will be performed to compare adding empagliflozin . The results will be published in a peer-review journal.

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Key information

Conditions

Kidney Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Labbafinezhd Hospital, Tehran, Iran

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About this study

With the purpose of studying the antioxidant activity of empagloflozin 25mg will add on insulin in 20 patients after kidney transplant and will compare with 20 diabetic recipient of kidney transplant on insulin therapy alone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with type 2 diabetes
  • HbA1c: 6.5-9.0%
  • post kidney transplant
  • stable graft function

Exclusion criteria

  • pancreas and kidney transplant
  • history of recurrent urinary tract infection

Treatment and study plan

Empagliflozin 25 MG

Drug

25 mg

Insulin

Drug

Insulin

Primary outcomes

  1. serum level of superoxide dismutase

    Time frame: Change from baseline after 90 days of intervention

    Serum level of antioxidant levels

Secondary outcomes

  1. Plasma levels of malondialdehyde

    Time frame: Change from baseline after 90 days of intervention

    Serum level of antioxidant levels

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Effects of Empagliflozin in Reducing Oxidative Stress of Diabetic Recipients After Kidney Transplantation

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 8, 2021
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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