Empagliflozin and Physical Function in CKD (EMPA-FUNCTION) Feasibility Study
K
Kenneth Lim
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
24 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The purpose of the study is to assess the therapeutic benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors in improving physical function in End Stage Renal disease (ESRD) patients. The study is using the drug Empagliflozin, a FDA approved drug for patients with advanced CKD. This study will be investigating the effects Empagliflozin has on physical function, a use that has not been examined in a clinical trial.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Recruitment will target non-diabetic dialysis patients. Subjects will be recruited from our outpatient dialysis clinics of the IU Division of Nephrology in accordance with IU recruitment and local clinic policies. Patients may also be recruited from the DaVita, DCI, or Fresenius clinics affiliated with the IU Division of Nephrology. Personnel from the IUSM Division of Nephrology will review medical charts from nephrology clinics for pre-screening to determine potential eligibility. The potential subjects will be contacted by phone or visited by study staff during their outpatient dialysis session. Information about the study may be discussed with interested potential subjects by research personnel by phone, email or in person as preferred by the subject/clinic.
Detailed description of study
What will happen during the study?
- We will conduct a randomized, single blind, placebo-controlled feasibility study that will recruit a total of n=24 patients with non-diabetic CKD stage 5D on hemodialysis to receive either Empagliflozin 10mg or Placebo for 8 weeks.Patients will be blinded to the study drug.
- All patients will undergo comprehensive physical function and NIRS before and after intervention.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: End Stage Renal Disease, Chronic Kidney Disease, ESRD, CKD
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria
• CKD stage 5D patients on hemodialysis
• Must be receiving maintenance hemodialysis 3 times weekly for at least 3 months.
• ≥ 18 years of age.
• All races, ethnicities, and genders.
• English speaking patients.
• Agrees to participate in the FIT Core study (IRB # 1707550885).
Exclusion Criteria
• Patients who are not already on an SGLT2 inhibitor
• Patients with residual kidney function as defined as making urine > 300 mls per day
• Patients with malignancy requiring chemotherapy or metastatic disease.
• History of diabetes per the American Diabetes Association established criteria (including history of remission).
• Acute coronary syndrome or any major surgery within the last 3 months.
• Systolic blood pressure < 90mmHg
• Patients unable to exercise due to musculoskeletal issues.
• Patients likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the patient, research team and Investigator’s knowledge.
• Patients with active implanted medical devices (e.g. cardiac pacemaker, defibrillators).
• Pregnancy or breastfeeding.
• Contraindications to CPET testing as described in our CPET standard operating procedure (SOP)
• Weight > 300 pounds.
• CKD stage 5D patients on hemodialysis
• Must be receiving maintenance hemodialysis 3 times weekly for at least 3 months.
• ≥ 18 years of age.
• All races, ethnicities, and genders.
• English speaking patients.
• Agrees to participate in the FIT Core study (IRB # 1707550885).
Exclusion Criteria
• Patients who are not already on an SGLT2 inhibitor
• Patients with residual kidney function as defined as making urine > 300 mls per day
• Patients with malignancy requiring chemotherapy or metastatic disease.
• History of diabetes per the American Diabetes Association established criteria (including history of remission).
• Acute coronary syndrome or any major surgery within the last 3 months.
• Systolic blood pressure < 90mmHg
• Patients unable to exercise due to musculoskeletal issues.
• Patients likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the patient, research team and Investigator’s knowledge.
• Patients with active implanted medical devices (e.g. cardiac pacemaker, defibrillators).
• Pregnancy or breastfeeding.
• Contraindications to CPET testing as described in our CPET standard operating procedure (SOP)
• Weight > 300 pounds.
Updated on
01 May 2025.
Study ID: NEPH-IIR-EMPA-FUNCTION, 22652
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
