Effects of Empagliflozin in Reducing Oxidative Stress After Kidney Transplantation

NCT ID: NCT04918407

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Transplant; Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Empagliflozin

Adding 25mg Empagliflozin on Insulin

Group Type EXPERIMENTAL

Empagliflozin 25 MG

Intervention Type DRUG

25 mg

Insulin

Intervention Type DRUG

Insulin

Insulin alone

Just contriling the blood glucose with Insulin

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Insulin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Empagliflozin 25 MG

25 mg

Intervention Type DRUG

Insulin

Insulin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

nooshin dalili

Assistant Professor of SBMU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nooshin Dalili

Role: PRINCIPAL_INVESTIGATOR

Shahid Beheshti University of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Labbafinezhd Hospital

Tehran, , Iran

Site Status

SBMU

Tehran, , Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SBMU98543

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Empagliflozin in ESKD - A Feasibility Study
NCT05687058 RECRUITING PHASE1/PHASE2
SGLT2i in Diabetic Patients with Renal Transplantation
NCT06731231 ACTIVE_NOT_RECRUITING PHASE1/PHASE2