Phase 4 Chronic Kidney Disease Trial, Recruiting NCT06013865 Sponsor: VA Office of Research and Development Condition: Chronic Kidney Disease
Back to Chronic Kidney Disease

Phase 4 Chronic Kidney Disease Trial, Recruiting

NCT06013865
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be an adult (over 18 years old) of any gender, race, or ethnicity
  • You must be able to understand the study information and give your written consent to participate
  • You must have received your first or second kidney transplant at least 3 months ago
  • If you have Type 2 diabetes or diabetes that developed after your transplant, your kidney function test results must fall within a specific range, and you may also qualify if you have higher kidney function but protein in your urine (confirm with trial site)
  • If you do not have Type 2 diabetes or post-transplant diabetes, your kidney function test results must fall within a slightly different specific range, or you may qualify if you have higher kidney function but protein in your urine (confirm with trial site)

Who may not be able to join:

  • You are unwilling or unable to give written consent or follow the study plan
  • You have had a pancreas transplant in the past
  • Your kidney function is below a certain level, or your kidney function has been declining rapidly over the past year
  • You have Type 2 diabetes that is very poorly controlled, with a recent blood sugar average (A1C) above 12%
  • You have had more than 2 urinary tract infections (UTIs) in the past year, a UTI that required a hospital stay in the last year, or a serious blood infection from a UTI in the last year
  • You have taken a type of diabetes medication called an SGLT2 inhibitor in the last 90 days
  • You have a known allergy to SGLT2 inhibitor medications
  • You have Type 1 diabetes
  • You have a history of a serious complication called diabetic ketoacidosis
  • You have a permanent urinary catheter or a surgically rerouted urinary system
  • You have had a kidney transplant rejection episode in the last 3 months
  • You have had a serious heart event (such as a heart attack or stroke) within the last 3 months
  • You have severe heart failure (confirm with trial site)
  • You currently have an active fungal skin infection in the groin or genital area
  • You have had an amputation due to poor circulation or diabetic foot wounds in the past year
  • You have had a cancer diagnosis (other than certain minor skin cancers) within the last 2 years
  • You currently have an active serious infection, such as tuberculosis or a fungal, viral, or bacterial infection
  • You are living with HIV, even if it is well managed with medication
  • You have had an active Hepatitis B infection detected by a blood test within the last 6 months
  • You have Hepatitis C and have not shown a sustained clear result (no virus detected) for more than 12 weeks after treatment
  • You are currently pregnant
  • The study doctor believes there is another reason that joining the study would not be appropriate for you (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Roslyn B Mannon, MD, Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Phone: (205) 999-7362

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
5 April 2024
Est. completion
31 March 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Discontinuation of Empagliflozin

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov