Autosomal Dominant Polycystic Kidney DiseasePhase 2SIDIANCT06435858
Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
A Phase 2 study testing Empagliflozin in people with Autosomal Dominant Polycystic Kidney Disease, run by Cantonal Hospital Graubuenden at 2 sites in Switzerland.
Trial summary
This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin. Patients will be randomized into two groups and take Empagliflozin or a Placebo for 2 weeks with a wash-out period of 2 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- 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
- 16 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Sep 2024to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Patients 18-75 years old with ADPKD, defined according to international diagnostic and classification criteria14, treated at Cantonal Hospital Graubünden (KSGR) and the University Hospital Zürich (USZ) independent of baseline treatment with the vasopressin receptor antagonist Tolvaptan
- Informed consent as documented by signature
Who cannot join
- - renal replacement therapy or kidney allograft recipient
- chronic kidney disease CKD KDIGO Stage G4 (eGFR under 30ml/min/1.73m2)
- patients younger 18 years of age
- Diabetes mellitus type 1
- recurrent urinary tract infections (UTI) defined as more than 3 infections requiring antibiotic treatment or over 1 requiring hospitalization/year.
- Patients with uncontrolled hypertension (defined as ambulatory systolic BP over 180mmHg), liver cirrhosis (Child Pugh B and C)
Show all 15Show fewer
- Patients not able or not willing to stop the following medications during the study period of participation in the trial:
- Thiazide diuretics
- Carbonic anhydrase inhibitors
- Sodium bicarbonate
- 1, 25 (OH) vitamin D (calcitriol)
- Bisphosphonate, denosumab, teriparatide
- Pregnant or lactating women
- Known allergy to study drug
- Inability to understand and follow the protocol
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Cantonal Hospital Graubuenden
Chur, Kanton Graubünden, 7000
University Hospital Zurich, Division of Nephrology
Zurich, Canton of Zurich, 8091
About this study
This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.
Patients will be randomized into two groups and take Empagliflozin or a Placebo for 2 weeks with a wash-out period of 2 weeks. The primary outcome is tubular handling of the divalent ions calcium, phosphate and magnesium. Secondary outcomes include diuresis, safety and tolerability.
Read the detailed description
This investigator-initiated randomised, single-blind, placebo-controlled cross-over study aims to better understand tubular electrolyte handling of divalent ions in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.
After randomization, at week 0, participants collect 24-hour urine sample and a patient visit to assess vitals and blood tests takes place. After this visit, period 1 starts with a 2-week treatment of either Empagliflozin 10mg or Placebo.
At week 2, the second 24-hour-urine sample and 2. patient visit and blood test take place. After this visit, wash-out period for 2 weeks starts where no study drug will be administered At week 4, the period 2, the crossover-period starts for an additional 2 weeks. At week 6; a final and third 24-hour urine sample, clinical visit and blood test takes place.
At week 3 \& 7, a phone consultation will assess safety.
- Being tested
- Empagliflozin, Placebo
- Keywords
- phosphate, calcium, magnesium, Empagliflozin, ADPKD
- 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 10mg
PlaceboDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Empagliflozin 10mg Receives: Drug: Empagliflozin |
| Control | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Urinary Phosphate
Total phosphate excretion measured in a 24-hour urine collection at the end of each treatment period.
Measured: End of each 14 day treatment period
24-hour Urinary Calcium Excretion
Effect of empagliflozin compared with placebo on 24-hour urinary calcium excretion after each 14-day treatment period in a randomized crossover trial.
Measured: End of each 14-day treatment period
24-hour Urinary Magnesium Excretion
Effect of empagliflozin compared with placebo on 24-hour urinary magnesium excretion after each 14-day treatment period in a randomized crossover trial.
Measured: End of each 14-day treatment period
Secondary outcomes (4)
Serum Phosphate
Effect of empagliflozin compared with placebo on serum phosphate after each 14-day treatment period.
Measured: End of each 14-day treatment period
Serum Calcium
Effect of empagliflozin compared with placebo on serum calcium after each 14-day treatment period.
Measured: End of each 14-day treatment period
Serum Magnesium
Effect of empagliflozin compared with placebo on serum magnesium after each 14-day treatment period.
Measured: End of each 14-day treatment period
24-hour Urine Volume
Total urine volume collected over 24 hours at the end of each treatment period.
Measured: End of each 14-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Sep 2024
- Primary completion1 Jul 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Investigator-initiated randomised, single-blind, placebo-controlled, cross-over study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital Graubuenden
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Patrick Hofmann, Cantonal Hospital Graubuenden
- Investigators
- Thomas Fehr, MD, Principal investigator, Cantonal Hospital GraubuendenPatrick Hofmann, MD, Principal investigator, Cantonal Hospital Graubuenden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435858
- Sponsor's protocol ID
- 2024-00070
- Acronym
- SIDIA
- Status last verified
- Sep 2026
- First submitted
- 24 May 2024
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The local ethics committee approval does not include individual participant data sharing.
Publications
St 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 39356039
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT06435858
- Acronym / sponsor ID
- SIDIA / 2024-00070
- Keywords
- phosphate, calcium, magnesium, Empagliflozin, ADPKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cantonal Hospital GraubuendenUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Posted 22 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.
Patients will be randomized into two groups and take Empagliflozin or a Placebo for 2 weeks with a wash-out period of 2 weeks. The primary outcome is tubular handling of the divalent ions calcium, phosphate and magnesium. Secondary outcomes include diuresis, safety and tolerability.
Detailed description
This investigator-initiated randomised, single-blind, placebo-controlled cross-over study aims to better understand tubular electrolyte handling of divalent ions in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.
After randomization, at week 0, participants collect 24-hour urine sample and a patient visit to assess vitals and blood tests takes place. After this visit, period 1 starts with a 2-week treatment of either Empagliflozin 10mg or Placebo.
At week 2, the second 24-hour-urine sample and 2. patient visit and blood test take place. After this visit, wash-out period for 2 weeks starts where no study drug will be administered At week 4, the period 2, the crossover-period starts for an additional 2 weeks. At week 6; a final and third 24-hour urine sample, clinical visit and blood test takes place.
At week 3 \& 7, a phone consultation will assess safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Investigator-initiated randomised, single-blind, placebo-controlled, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: EmpagliflozinEmpagliflozin 10mg |
| Control | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - Patients 18-75 years old with ADPKD, defined according to international diagnostic and classification criteria14, treated at Cantonal Hospital Graubünden (KSGR) and the University Hospital Zürich (USZ) independent of baseline treatment with the vasopressin receptor antagonist Tolvaptan
- Informed consent as documented by signature
Key exclusion criteria (15 listed)
- - renal replacement therapy or kidney allograft recipient
- chronic kidney disease CKD KDIGO Stage G4 (eGFR under 30ml/min/1.73m2)
- patients younger 18 years of age
- Diabetes mellitus type 1
- recurrent urinary tract infections (UTI) defined as more than 3 infections requiring antibiotic treatment or over 1 requiring hospitalization/year.
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 10mg | Drug | Intervention |
| PlaceboPlacebo capsule | Drug | Control |
Primary outcome
24-hour Urinary Phosphate
Time frame: End of each 14 day treatment period
Total phosphate excretion measured in a 24-hour urine collection at the end of each treatment period.
24-hour Urinary Calcium Excretion
Time frame: End of each 14-day treatment period
Effect of empagliflozin compared with placebo on 24-hour urinary calcium excretion after each 14-day treatment period in a randomized crossover trial.
24-hour Urinary Magnesium Excretion
Time frame: End of each 14-day treatment period
Effect of empagliflozin compared with placebo on 24-hour urinary magnesium excretion after each 14-day treatment period in a randomized crossover trial.
4 secondary outcomes
Serum Phosphate
Time frame: End of each 14-day treatment period
Serum Calcium
Time frame: End of each 14-day treatment period
Serum Magnesium
Time frame: End of each 14-day treatment period
24-hour Urine Volume
Time frame: End of each 14-day treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: No. The local ethics committee approval does not include individual participant data sharing.
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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.
Thomas Fehr, MD principal investigator
Cantonal Hospital Graubuenden
Patrick Hofmann, MD principal investigator
Cantonal Hospital Graubuenden
2 sites 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 Autosomal Dominant Polycystic Kidney Disease, run by Cantonal Hospital Graubuenden at 2 sites in Switzerland.
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 2 inclusion and 15 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: finished, as of the sponsor's last update on 22 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 2 sites in Switzerland. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
24-hour Urinary Phosphate (time frame: End of each 14 day treatment period). The study lists 3 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 NCT06435858, which also lists 1 linked publication.
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 22 Sep 2026.