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Kidney disease

Empagliflozin Treatment in Kidney Transplant Recipients

Recruiting · 5 sites across 5 states

Study treatment at no costPHASE4

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging.

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging. Patient death with existing kidney graft function occurs in about half of all recipients over time. This is primarily due to the development of cardiovascular disease in a patient population with multiple preexisting cardiac disease risk factors. There has been little progress in improving outcomes in this area for over two decades. Recent studies in chronic kidney disease (CKD) patients using SGLT2 inhibitors (SGLT2i), regardless of the presence of type 2 diabetes mellitus (T2DM), results in both kidney protective and cardiac protective impacts and improved patient outcomes. However, kidney transplant recipients (KTRs) were excluded from these clinical trials due to concerns that these agents promote infection, diminish graft function, and may alter immunosuppressive drug levels that are the mainstay of patient's transplant therapy. There are limited published data of SGLT2i treatment of selected KTRs.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

  • Adult kidney transplant recipients (male or female, all races/ethnicities)
  • Able to understand and provide consent
  • Had a primary or secondary kidney transplant at least 3 months ago
  • Kidney-function requirements based on CKD-epi eGFR and urine albumin:creatinine ratio or protein:creatinine ratio
  • Either with T2DM/PTDM (post-transplant diabetes) or without T2DM/PTDM, as long as they meet the matching kidney-function rules

🚫 You may not be able to join if…

  • Can’t (or won’t) give written consent or follow the study plan
  • Prior pancreas transplant
  • Kidney function too low for the required group (eGFR below the cutoff stated for people with T2DM/PTDM vs without), or eGFR falling too much (as stated)
  • Recent or current issues that raise infection/serious risk (including frequent UTIs/urosepsis in the last year, indwelling Foley catheter or urinary diversion, or active serious infections)
  • Recent SGLT2 inhibitor use (within 90 days), allergy to SGLT2 inhibitors, type 1 diabetes, diabetic ketoacidosis, or recent acute rejection/MACE event

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults roughly 19–any age
  • Have Type 2 diabetes or Kidney disease
  • !Some conditions may not be a fit: Heart / cardiovascular disease
  • !Not for people who are pregnant or breastfeeding

What to expect, step by step

  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

Yes. This treatment has already been through earlier human studies for safety before reaching this stage.

What you need to know before you apply

What is this study testing?+

Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging.

Is it safe? Who makes sure of that?+

This is a study of an already-approved treatment (Phase 4). Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT06013865 · Locations: Illinois · Iowa · Nebraska · Pennsylvania · Tennessee