End Stage Renal Disease on DialysisPhase 4EMPA-PDNCT05671991
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
A Phase 4 study testing Empagliflozin 10 MG in people with End Stage Renal Disease on Dialysis, run by Yale University at 1 site in United States.
Trial summary
The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis. This is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week "pre… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients actively undergoing PD with a reliably functioning PD catheter
- Stable peritoneal dialysis prescription
- PD vintage > 3 months
- Age >18 years of age
Who cannot join
- History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
- Use of an SGLT2 inhibitor within the prior 30 days
- 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- Anemia with hemoglobin <8g/dL
- Inability to give written informed consent or follow study protocol
- Contraindication to receiving loop diuretics
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis.
This is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily.
Read the detailed description
Participants will undergo three study visits, and up to 4 safety visits, over 9 weeks.
At 7 AM in the first study visit, the participants will have taken 25mg empagliflozin once or matching placebo, thus producing peak plasma levels by 10 AM. One week later the participant will return for the crossed over to the alternate study drug.
At the conclusion of the 2nd study visit, all participants will be provided with empagliflozin 10mg tabs to be taken daily for 56 days (8 weeks). At each study visit and safety visit, participants will undergo a PET test.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Empagliflozin 25 mg vs Placebo, Empagliflozin 10 MG
- Keywords
- Peritoneal dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 mg vs PlaceboDrug
Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7
Empagliflozin 10 MGDrug
Chronic Study- Empagliflozin 10 mg for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin or Placebo in Acute | Experimental | Acute phase: Participants will receive 25 mg empagliflozin once on Day 0 or Day 7. Participants receive empaglifozin or placebo on Day 0. On Day 7, they will be crossed over to the alternate treatment. Receives: Drug: Empagliflozin 25 mg vs Placebo |
| Empagliflozin in Chronic | Active comparator | Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks Receives: Drug: Empagliflozin 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose absorption with empagliflozin vs. placebo
Total glucose absorption in grams with empagliflozin vs. placebo
Measured: Day 0 to Day 63
Secondary outcomes (6)
Ultrafiltration volume with empagliflozin vs. placebo- acute study
Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo.
Measured: at 4 hours
Change in plasma glucose levels with empagliflozin vs. placebo- acute study
Change in plasma glucose levels during PD dwell with empagliflozin vs. placebo- acute study
Measured: Day 0 to Day 63
Increase in natriuresis with empagliflozin vs. placebo-acute study
Natriuresis determined by FENa
Measured: Day 0 to Day 63
Change in peritoneal fluid inflammatory markers
Change in levels of IL-6 and CA-125 (in pg)
Measured: Day 0 to Day 63
Change in PET test parameters
Change in peritoneal equilibration test parameters, measurement of solute transport across the peritoneal membrane (standard test carried out in PD patients to assess solute trasnport across membrane)
Measured: Day 0 to Day 63
Change in total body water and extracellular water
Change in total body water and extracellular water, using heaving water (D20)
Measured: Day 0 to Day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo controlled, acute crossover study of empagliflozin in 30 chronic PD patients, with an 8 week "pre post" open label extension in all 23 patients where they will receive empagliflozin daily.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Jeffrey Testani, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671991
- Sponsor's protocol ID
- 2000031605
- Acronym
- EMPA-PD
- Status last verified
- Sep 2026
- First submitted
- 14 Dec 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT05671991
- Acronym / sponsor ID
- EMPA-PD / 2000031605
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- Peritoneal dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis.
This is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily.
Detailed description
Participants will undergo three study visits, and up to 4 safety visits, over 9 weeks.
At 7 AM in the first study visit, the participants will have taken 25mg empagliflozin once or matching placebo, thus producing peak plasma levels by 10 AM. One week later the participant will return for the crossed over to the alternate study drug.
At the conclusion of the 2nd study visit, all participants will be provided with empagliflozin 10mg tabs to be taken daily for 56 days (8 weeks). At each study visit and safety visit, participants will undergo a PET test.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, placebo controlled, acute crossover study of empagliflozin in 30 chronic PD patients, with an 8 week "pre post" open label extension in all 23 patients where they will receive empagliflozin daily.
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin or Placebo in Acute | Experimental | Drug: Empagliflozin 25 mg vs PlaceboAcute phase: Participants will receive 25 mg empagliflozin once on Day 0 or Day 7. Participants receive empaglifozin or placebo on Day 0. On Day 7, they will be crossed over to the alternate treatment. |
| Empagliflozin in Chronic | Active comparator | Drug: Empagliflozin 10 MGChronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients actively undergoing PD with a reliably functioning PD catheter
- Stable peritoneal dialysis prescription
- PD vintage > 3 months
- Age >18 years of age
Key exclusion criteria (6 listed)
- History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
- Use of an SGLT2 inhibitor within the prior 30 days
- 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- Anemia with hemoglobin <8g/dL
- Inability to give written informed consent or follow study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 25 mg vs PlaceboAcute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7 | Drug | Empagliflozin or Placebo in Acute |
| Empagliflozin 10 MGChronic Study- Empagliflozin 10 mg for 8 weeks | Drug | Empagliflozin in Chronic |
Primary outcome
Glucose absorption with empagliflozin vs. placebo
Time frame: Day 0 to Day 63
Total glucose absorption in grams with empagliflozin vs. placebo
6 secondary outcomes
Ultrafiltration volume with empagliflozin vs. placebo- acute study
Time frame: at 4 hours
Change in plasma glucose levels with empagliflozin vs. placebo- acute study
Time frame: Day 0 to Day 63
Increase in natriuresis with empagliflozin vs. placebo-acute study
Time frame: Day 0 to Day 63
Change in peritoneal fluid inflammatory markers
Time frame: Day 0 to Day 63
Change in PET test parameters
Time frame: Day 0 to Day 63
Change in total body water and extracellular water
Time frame: Day 0 to Day 63
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Testani, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 10 MG in people with End Stage Renal Disease on Dialysis, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose absorption with empagliflozin vs. placebo (time frame: Day 0 to Day 63). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.