Polycystic Kidney, Autosomal DominantPhase 2NCT05510115
Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease
A Phase 2 study testing Empagliflozin in people with Polycystic Kidney, Autosomal Dominant, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigator proposes a pilot randomized clinical trial to determine the safety and tolerability of empagliflozin in ADPKD patients. To achieve this, the investigator will conduct a 12-month parallel-group, randomized, double-blind, placebo-controlled trial in 50 ADPKD patients with an eGFR 30-90 mL/min/1.73m2. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Polycystic Kidney, Autosomal Dominant
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2022to 1 Aug 2026
- Phase
- Phase 2
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Autosomal Dominant Polycystic Kidney Disease (ADPKD) as defined by modified Pei-Ravine Criteria;
- Age 18-55 yrs;
- Estimated Glomerular Filtration Rate (eGFR) 30-90 ml/min/1.73m2;
- Mayo imaging-based risk classification 1C, 1D, or 1E;
- Stable renal function over prior 3 months.
Who cannot join
- Known diabetes mellitus;
- Fasting Glucose >120 mg/dL;
- HbA1C≥6.5%;
- Seated systolic blood pressure <100 mm Hg;
- Seated systolic blood pressure >160 mm Hg;
- Known heart failure with reduced ejection fraction (HFrEF);
Show all 12Show fewer
- Current use of loop diuretic;
- Current use of tolvaptan or other V2 receptor antagonist;
- Current urinary tract or urogenital infection;
- Pregnant or lactating;
- Vascular claudication, lower extremity skin infection or ulcers;
- Contraindication to magnetic resonance imaging (e.g., severe claustrophobia, implanted ferromagnetic device).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Coloardo Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
The investigator proposes a pilot randomized clinical trial to determine the safety and tolerability of empagliflozin in ADPKD patients. To achieve this, the investigator will conduct a 12-month parallel-group, randomized, double-blind, placebo-controlled trial in 50 ADPKD patients with an eGFR 30-90 mL/min/1.73m2.
Read the detailed description
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by development and continued growth of numerous fluid-filled kidney cysts that result in ultimate loss of kidney function in the majority of individuals. ADPKD manifestations are not limited to the kidney. It is well established that arterial stiffness, an important predictor of future cardiovascular events and mortality, is present early in the course of ADPKD. Sodium-glucose cotransporters-2 inhibitors (SGLT2i) have a track record of tolerability and safety in patients with diabetic and non-diabetic kidney disease. Studies of SGLT2i have been extremely encouraging and the expectation is that these treatments will become standard of care for diabetic and non-diabetic kidney disease; however, the mechanism of action is not fully understood and seems non-specific with regards to disease etiology. The potential benefit of SGLT2i has not been examined in ADPKD, as major trials of SGLT2i in non-diabetic chronic kidney disease (CKD) have excluded patients with ADPKD. It is also important to note the potential benefits of SGLT2i outside of delaying loss of kidney function, as these class of drugs have been shown to provide a mortality benefit for patients across the CKD spectrum. Thus, novel interventions to slow kidney disease progression and reduce vascular morbidity within ADPKD population are of clinical importance.
Limited data suggests SGLT2i may stimulate vasopressin and vasopressin receptor expression by causing glucosuria, natriuresis, and glucose osmotic diuresis, at least in patients and animal models without ADPKD. Vasopressin is known to stimulate cyst growth in ADPKD and promote disease progression. SGLT2i have been studied in animal models of ADPKD, with conflicting data. Some studies in rodent ADPKD models treated with SGLT2i failed to show a significant reduction in cyst growth. However, because of SGLT2i's beneficial effects on kidney function, vascular function, and mortality in non-ADPKD patients with CKD, further investigations of SGLT2i in patients with ADPKD are needed.
Primary Outcome Measure (Aim1): Safety will be assessed by laboratory testing and recording of adverse events. Tolerability will be assessed by subject drop-out rate due to adverse events and the proportion tolerating the maximal dose of study drug. Adherence to the intervention will be assessed by counting the returned number of tablets during check-in visits. Subjects will have check-in visits every 2 weeks the 1st month, monthly on month 2 and 3 and then every 3 months until the end of the study. Subjects will discuss issues with tolerability or treatment-emergent adverse events with a member of the clinical staff who is blinded to treatment status.
Secondary (Exploratory) Outcome Measures (Aim 2): (a) Height-adjusted total kidney volume will be examined by magnetic resonance imaging, at baseline, 3 months and 12 months after treatment with empagliflozin or placebo; (b) Estimated glomerular filtration rate will be estimated from serum creatinine using the revised "race-neutral "CKD-Epi equation, at baseline, 2 weeks, 4 weeks, 8 weeks, 3 months, 6 months, 9 months and 12 months after treatment with empagliflozin or placebo; (c) Aortic stiffness will be evaluated as aortic pulse wave velocity, at baseline, 3 months and 12 months after treatment with empagliflozin or placebo; (d) Plasma copeptin levels and urinary kidney injury molecule-1 will be measured at baseline, 3 months and 12 months after treatment with empagliflozin or placebo; and (e) Patient related outcomes will be measured using the ADPKD Impact Scale (ADPKD-IS) at baseline, 3 months and 12 months after treatment with empagliflozin or placebo.
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Being tested
- Empagliflozin, Placebo
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Empagliflozin: The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3furanyl]oxy]phenyl]methyl]phenyl]-, (1S). Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile; soluble in 50% acetonitrile/water; and practically insoluble in toluene. Empagliflozin power will be added in white and bovine origin gelatin capsules. Each capsule of empagliflozin will contain 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: microcrystalline cellulose magnesium, stearate, dicalcium phosphate, and silicone dioxide.
PlaceboDrug
Placebo capsules will be matched in size and color to empagliflozin capsules. Each placebo capsule will contain the following inactive ingredients: microcrystalline cellulose magnesium, stearate, dicalcium phosphate, and silicone dioxide.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Empagliflozin Receives: Drug: Empagliflozin |
| Placebo comparator | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the intervention
Safety will be assessed by laboratory testing and recording of adverse events.
Measured: Baseline, check-in visits (every 2 weeks the 1st month, monthly on month 2 and 3 and then every 3 months until the end of the study), post-testing (12-months).
Tolerability and adherence of the intervention
Tolerability will be defined by the percentage of participants who are taking 25mg/day of study drug and who report affirmatively to the question "Can you tolerate this dose of the study drug/placebo for the rest of your life?
Measured: Baseline, check-in visits (every 2 weeks the 1st month, monthly on month 2 and 3 and then every 3 months until the end of the study), post-testing (12-months).
Secondary outcomes (5)
Height-Adjusted Total kidney volume
To assess kidney growth, we will measure change in height-adjusted total kidney volume by magnetic resonance imaging at baseline, 3 months and 12 months.
Measured: Baseline, check-in visit (3 months), post-testing (12-months)
Estimated glomerular filtration rate
GFR will be estimated from serum creatinine using the revised "race-neutral "CKD-Epi equation.
The effect of empagliflozin as compared with placebo on the rate of eGFR decline will be analyzed in the acute phase (baseline to month 2), chronic phase (month 2 until the end of treatment), and total slope to month 12. The effect of SGLT2i vs placebo on the chronic phase slope of eGFR will be considered as the exploratory measure of efficacy.
Measured: Baseline, 2, 4, 8 weeks, check-in visit (3 months), 6, 9, post-testing (12-months).
Aortic Pulse Wave Velocity (aPWV)
A transcutaneous custom tonometer (SphygmoCor XCEL PWA and PWV System; Atcor Medical Inc, Naperville IL) will be positioned at the carotid and femoral arteries and aPWV will be calculated as the distance between recording sites/time between the foot of the carotid and femoral arterial waveforms. Data will be expressed as cm/s.
Measured: Baseline, check-in visit (3 months), post-testing (12 months).
Mechanistic Biomarkers
Venous blood samples will be analyzed for the following circulating mechanistic biomarker: Plasma copeptin.
Urine samples will be analyzed for the following mechanistic biomarker:
Kidney Injury Molecule -1 (KIM-1).
Measured: Baseline, check-in visit (3 months), post-testing (12 months).
Patient Related Outcomes
The ADPKD Impact Scale (ADPKD-IS) includes 18 items representing 3 distinct domains (physical function, fatigue, and emotional function.
Measured: Baseline, check-in visit (3 months), post-testing (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start18 Nov 2022
- Primary completion18 Mar 2026
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Polycystic Kidney, Autosomal DominantStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Michel B Chonchol, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510115
- Sponsor's protocol ID
- 22-0616
- Other IDs
- 1R01DK131755-01A1
- Status last verified
- May 2025
- First submitted
- 11 Aug 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All NIH applicable guidelines regarding data sharing will be followed. At the conclusion of the study, data that is coded with a number will be made available to qualified individuals within the scientific community who apply for data use. The results and outcomes of the studies will be made generally available by publication with journal articles submitted to PubMed Central in compliance with NIH access guidelines.
Publications
Seliger SL, Gitomer B, You Z, Wang W, Ostrow A, Andrews E, Diggs C, George D, West M, Nowak KL, Watnick T, Chonchol M. Empagliflozin Therapy in Autosomal Dominant Polycystic Kidney Disease: A Feasibility Randomized Controlled Trial. J Am Soc Nephrol. 2026 Oct 24. doi: 10.1681/ASN.0000001271. Online ahead of print.
PubMed 42925875Nowak KL, Chonchol M. Cardiovascular-Kidney-Metabolic Syndrome in Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2026 Sep 25. doi: 10.1681/ASN.0000001291. Online ahead of print. No abstract available.
PubMed 42789922Eswarappa M, Madden E, Shlipak MG, Cui X, Mrug M, Estrella MM, Park M. Sodium-Glucose Cotransporter-2 Inhibitor Therapy and Longitudinal Changes in Kidney Function among Veterans with Autosomal Dominant Polycystic Kidney Disease. Clin J Am Soc Nephrol. 2025 May 16;20(7):940-949. doi: 10.2215/CJN.0000000725.
PubMed 40377984St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PubMed 39356039Hogan MC, Simmons K, Ullman L Jr, Gondal M, Dahl NK. Beyond Loss of Kidney Function: Patient Care in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2023 Dec 1;4(12):1806-1815. doi: 10.34067/KID.0000000000000296. Epub 2023 Nov 27.
PubMed 38010035
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT05510115
- Acronym / sponsor ID
- 22-0616
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Maryland, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 22 Aug 2022 (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 investigator proposes a pilot randomized clinical trial to determine the safety and tolerability of empagliflozin in ADPKD patients. To achieve this, the investigator will conduct a 12-month parallel-group, randomized, double-blind, placebo-controlled trial in 50 ADPKD patients with an eGFR 30-90 mL/min/1.73m2.
Detailed description
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by development and continued growth of numerous fluid-filled kidney cysts that result in ultimate loss of kidney function in the majority of individuals. ADPKD manifestations are not limited to the kidney. It is well established that arterial stiffness, an important predictor of future cardiovascular events and mortality, is present early in the course of ADPKD. Sodium-glucose cotransporters-2 inhibitors (SGLT2i) have a track record of tolerability and safety in patients with diabetic and non-diabetic kidney disease. Studies of SGLT2i have been extremely encouraging and the expectation is that these treatments will become standard of care for diabetic and non-diabetic kidney disease; however, the mechanism of action is not fully understood and seems non-specific with regards to disease etiology. The potential benefit of SGLT2i has not been examined in ADPKD, as major trials of SGLT2i in non-diabetic chronic kidney disease (CKD) have excluded patients with ADPKD. It is also important to note the potential benefits of SGLT2i outside of delaying loss of kidney function, as these class of drugs have been shown to provide a mortality benefit for patients across the CKD spectrum. Thus, novel interventions to slow kidney disease progression and reduce vascular morbidity within ADPKD population are of clinical importance.
Limited data suggests SGLT2i may stimulate vasopressin and vasopressin receptor expression by causing glucosuria, natriuresis, and glucose osmotic diuresis, at least in patients and animal models without ADPKD. Vasopressin is known to stimulate cyst growth in ADPKD and promote disease progression. SGLT2i have been studied in animal models of ADPKD, with conflicting data. Some studies in rodent ADPKD models treated with SGLT2i failed to show a significant reduction in cyst growth. However, because of SGLT2i's beneficial effects on kidney function, vascular function, and mortality in non-ADPKD patients with CKD, further investigations of SGLT2i in patients with ADPKD are needed.
Primary Outcome Measure (Aim1): Safety will be assessed by laboratory testing and recording of adverse events. Tolerability will be assessed by subject drop-out rate due to adverse events and the proportion tolerating the maximal dose of study drug. Adherence to the intervention will be assessed by counting the returned number of tablets during check-in visits. Subjects will have check-in visits every 2 weeks the 1st month, monthly on month 2 and 3 and then every 3 months until the end of the study. Subjects will discuss issues with tolerability or treatment-emergent adverse events with a member of the clinical staff who is blinded to treatment status.
Secondary (Exploratory) Outcome Measures (Aim 2): (a) Height-adjusted total kidney volume will be examined by magnetic resonance imaging, at baseline, 3 months and 12 months after treatment with empagliflozin or placebo; (b) Estimated glomerular filtration rate will be estimated from serum creatinine using the revised "race-neutral "CKD-Epi equation, at baseline, 2 weeks, 4 weeks, 8 weeks, 3 months, 6 months, 9 months and 12 months after treatment with empagliflozin or placebo; (c) Aortic stiffness will be evaluated as aortic pulse wave velocity, at baseline, 3 months and 12 months after treatment with empagliflozin or placebo; (d) Plasma copeptin levels and urinary kidney injury molecule-1 will be measured at baseline, 3 months and 12 months after treatment with empagliflozin or placebo; and (e) Patient related outcomes will be measured using the ADPKD Impact Scale (ADPKD-IS) at baseline, 3 months and 12 months after treatment with empagliflozin or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: EmpagliflozinEmpagliflozin |
| Placebo comparator | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Autosomal Dominant Polycystic Kidney Disease (ADPKD) as defined by modified Pei-Ravine Criteria;
- Age 18-55 yrs;
- Estimated Glomerular Filtration Rate (eGFR) 30-90 ml/min/1.73m2;
- Mayo imaging-based risk classification 1C, 1D, or 1E;
- Stable renal function over prior 3 months.
Key exclusion criteria (12 listed)
- Known diabetes mellitus;
- Fasting Glucose >120 mg/dL;
- HbA1C≥6.5%;
- Seated systolic blood pressure <100 mm Hg;
- Seated systolic blood pressure >160 mm Hg;
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 |
|---|---|---|
| EmpagliflozinEmpagliflozin: The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3furanyl]oxy]phenyl]methyl]phenyl]-, (1S). Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile; soluble in 50% acetonitrile/water; and practically insoluble in toluene. Empagliflozin power will be added in white and bovine origin gelatin capsules. Each capsule of empagliflozin will contain 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: microcrystalline cellulose magnesium, stearate, dicalcium phosphate, and silicone dioxide. | Drug | Experimental |
| PlaceboPlacebo capsules will be matched in size and color to empagliflozin capsules. Each placebo capsule will contain the following inactive ingredients: microcrystalline cellulose magnesium, stearate, dicalcium phosphate, and silicone dioxide. | Drug | Placebo comparator |
Primary outcome
Safety of the intervention
Time frame: Baseline, check-in visits (every 2 weeks the 1st month, monthly on month 2 and 3 and then every 3 months until the end of the study), post-testing (12-months).
Safety will be assessed by laboratory testing and recording of adverse events.
Tolerability and adherence of the intervention
Time frame: Baseline, check-in visits (every 2 weeks the 1st month, monthly on month 2 and 3 and then every 3 months until the end of the study), post-testing (12-months).
Tolerability will be defined by the percentage of participants who are taking 25mg/day of study drug and who report affirmatively to the question "Can you tolerate this dose of the study drug/placebo for the rest of your life?
5 secondary outcomes
Height-Adjusted Total kidney volume
Time frame: Baseline, check-in visit (3 months), post-testing (12-months)
Estimated glomerular filtration rate
Time frame: Baseline, 2, 4, 8 weeks, check-in visit (3 months), 6, 9, post-testing (12-months).
Aortic Pulse Wave Velocity (aPWV)
Time frame: Baseline, check-in visit (3 months), post-testing (12 months).
Mechanistic Biomarkers
Time frame: Baseline, check-in visit (3 months), post-testing (12 months).
Patient Related Outcomes
Time frame: Baseline, check-in visit (3 months), post-testing (12 months)
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 1 May 2026.
- Derived from this study: PubMed 42925875Seliger SL, Gitomer B, You Z, Wang W, Ostrow A, Andrews E, Diggs C, George D, West M, Nowak KL, Watnick T, Chonchol M. Empagliflozin Therapy in Autosomal Dominant Polycystic Kidney Disease: A Feasibility Randomized Controlled Trial. J Am Soc Nephrol. 2026 Oct 24. doi: 10.1681/ASN.0000001271. Online ahead of print.
- Derived from this study: PubMed 42789922Nowak KL, Chonchol M. Cardiovascular-Kidney-Metabolic Syndrome in Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2026 Sep 25. doi: 10.1681/ASN.0000001291. Online ahead of print. No abstract available.
- Derived from this study: PubMed 40377984Eswarappa M, Madden E, Shlipak MG, Cui X, Mrug M, Estrella MM, Park M. Sodium-Glucose Cotransporter-2 Inhibitor Therapy and Longitudinal Changes in Kidney Function among Veterans with Autosomal Dominant Polycystic Kidney Disease. Clin J Am Soc Nephrol. 2025 May 16;20(7):940-949. doi: 10.2215/CJN.0000000725.
- Derived from this study: PubMed 39356039St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
- Derived from this study: PubMed 38010035Hogan MC, Simmons K, Ullman L Jr, Gondal M, Dahl NK. Beyond Loss of Kidney Function: Patient Care in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2023 Dec 1;4(12):1806-1815. doi: 10.34067/KID.0000000000000296. Epub 2023 Nov 27.
- Individual participant dataSharing planned: Yes. All NIH applicable guidelines regarding data sharing will be followed. At the conclusion of the study, data that is coded with a number will be made available to qualified individuals within the scientific community who apply for data use. The results and outcomes of the studies will be made generally available by publication with journal articles submitted to PubMed Central in compliance with NIH access guidelines.
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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.
Michel B Chonchol, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin in people with Polycystic Kidney, Autosomal Dominant, run by University of Colorado, Denver 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 5 inclusion and 12 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 1 May 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety of the intervention (time frame: Baseline, check-in visits (every 2 weeks the 1st month, monthly on month 2 and 3 and then every 3 months until the end of the study), post-testing (12-months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05510115, which also lists 5 linked publications.
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 1 May 2026.