End Stage Renal DiseasePhase 2PRESERVENCT05250752
Reduction of Peritoneal Glucose Uptake With Use of SGLT2 in Humans Undergoing Peritoneal Dialysis Treatment
A Phase 2 study testing Dapagliflozin 10 MG [Farxiga] in people with End Stage Renal Disease and Peritoneal Dialysis Complication, run by Holbaek Sygehus at 1 site in Denmark.
Trial summary
End stage renal disease is annually diagnosed in about one thousand patients in Denmark, and one of the treatment modalities in renal replacement therapy is peritoneal dialysis with about 25 % of patients assigned to this treatment (Hommel2010). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Peritoneal Dialysis Complication
- What is being tested?
- Dapagliflozin 10 MG [Farxiga]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Nov 2021to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Written informed consent
- Age above 18 years of age
- In stable peritoneal dialysis for more than 14 days.
Who cannot join
- In treatment with SGLT2i currently or within the last 90 days.
- Treatment for peritoneal infection within the last 30 days.
- Any hospitalization within the last 30 days.
- Anaphylaxis to the IMP.
- Impaired lever function with ALAT above normal range within the last 6 month.
- Sever efflux problems during peritoneal dialysis for the last 14 days, judged by the investigator.
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- Non-menopausal defined as menstruation within the last 12 month without any other medical cause. Only applicable for female participants.
- Substance abuse, judged by the investigator.
- Incapable to follow study protocol, judged by the investigator.
- Previously included in this clinical trial and exposed to the IMP.
- Included in another clinical trial with exposure to any IMP within the last 30 days.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital Copenhagen - Holbaek
Holbæk, Region Sjælland, 4300
About this study
Official title: Reduction of Peritoneal Glucose Uptake With Use of SGLT2 in Humans Undergoing Peritoneal Dialysis Treatment. A Proof of Concept Phase 2a Clinical Trial.
End stage renal disease is annually diagnosed in about one thousand patients in Denmark, and one of the treatment modalities in renal replacement therapy is peritoneal dialysis with about 25 % of patients assigned to this treatment (Hommel2010). Peritoneal dialysis is based on the principle of filtering waste products to peritoneal fluid and by exchange of peritoneal fluid eliminate waste products from the body.
In peritoneal dialysis commonly used fluids contain glucose. Exposure to high glucose levels in peritoneal fluid during peritoneal dialysis has several side effects. Primarily, as glucose passes over and into the peritoneal membrane it causes local inflammation which leads to fibrosis over time (Zhou2016). Fibrosis limits the capacity of the exchange of water and waste products over the peritoneal membrane. The decrease of peritoneal exchange capacity is most commonly the reason for termination of peritoneal dialysis.
Read more
SGLT2-channels are identified in peritoneal mesothelial cells of rats (Debray-Carcia 2016), and most recently also in humans (Shentu2021). An in vitro model of human peritoneal mesothelial cells incubated with the SGLT2-inhibitor (empagliflozin) has shown significantly decrease in glucose uptake (Zhou2019). Exposure to intraperitoneal empagliflozin in rats, reduced the uptake of glucose over the peritoneal membrane significantly by 78 % and the ultrafiltration was increased (Zhou2019).
Currently, to our knowledge, no clinical trials have been conducted in humans attending peritoneal dialysis with the aim of investigating either the effect or safety of SGLT2i, as it is indeed the first of its kind, with the aim of including participants in peritoneal dialysis.
- Being tested
- Dapagliflozin 10 MG [Farxiga]
- Keywords
- SGLT2-inhibition, dapagliflozin
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MG [Farxiga]Drug
Primary end-points are measure before (day 0), on treatment (day 1 and day 3) and after treatment (day 21)
| Study group | Role | What they receive |
|---|---|---|
| On treatment | Other | Assigned to oral treatment with dapagliflozin 10 mg for three consecutive days. Receives: Drug: Dapagliflozin 10 MG [Farxiga] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal glucose uptake (mg/ dL)
Glucose level in peritoneal fluid during a four hour standardized peritoneal dialysis. Change in total glucose uptake before and after treatment (treatment periode of three days)
Measured: Day 0 (baseline), Day 3 (max dose of treatment)
Secondary outcomes (4)
Fluid volume (ml)
Fluid volume ultra-filtrated during peritoneal dialysis.
Measured: Measured at end of each peritoneal dialysis. Peritoneal dialysis done af Day 0, Day 1 (first day of treatment) and day 3 (max dose of treatment)
Plasma glucose level (mg/ dL)
Glucose levels in blood and peritoneal-fluid during peritoneal dialysis. Comparaison of maximal plasma level.
Measured: Measured at end of each peritoneal dialysis. Peritoneal dialysis done af Day 0, Day 1 (first day of treatment) and day 3 (max dose of treatment).
Pharmacokinetics (nmol)
Dapagliflozin and its metabolites levels in blood and peritoneal-fluid
Measured: Samples for biobank - samples drawn at end of each peritoneal dialysis. Peritoneal dialysis done af Day 0, Day 1 (first day of treatment) and day 3 (max dose of treatment). Samples are drawn every 30 minuttes during each peritoneal dialysis.
Adverse events (events)
Safety in terms of AE and/or SAE
Measured: At day 1 (first day of treatment), day 3 (max dose of treatment) and day 30 (four weeks after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start18 Nov 2021
- Primary completion27 Feb 2022 (estimated)
- Study completion31 Dec 2022 (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 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
- Not applicable
- Intervention model
- Single group
- Model description
- Cross-over. Off-On-Off treatment. Dose response
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morten Lindhardt, MD, PhD, Principal investigator, Copenhagen University Hospital - Holbaek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250752
- Sponsor's protocol ID
- HOL-MED-01-2021
- Acronym
- PRESERVE
- Status last verified
- Nov 2021
- First submitted
- 13 Jan 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data material used in this study are available from the corresponding author on reasonable request which will not conflict with the anonymity and confidentiality of the data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Peritoneal Glucose Uptake With Use of SGLT2 in Humans Undergoing Peritoneal Dialysis Treatment. A Proof of Concept Phase 2a Clinical Trial.
- ClinicalTrials.gov ID
- NCT05250752
- Acronym / sponsor ID
- PRESERVE / HOL-MED-01-2021
- Keywords
- SGLT2-inhibition, dapagliflozin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 27 Feb 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Feb 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.
End stage renal disease is annually diagnosed in about one thousand patients in Denmark, and one of the treatment modalities in renal replacement therapy is peritoneal dialysis with about 25 % of patients assigned to this treatment (Hommel2010). Peritoneal dialysis is based on the principle of filtering waste products to peritoneal fluid and by exchange of peritoneal fluid eliminate waste products from the body.
In peritoneal dialysis commonly used fluids contain glucose. Exposure to high glucose levels in peritoneal fluid during peritoneal dialysis has several side effects. Primarily, as glucose passes over and into the peritoneal membrane it causes local inflammation which leads to fibrosis over time (Zhou2016). Fibrosis limits the capacity of the exchange of water and waste products over the peritoneal membrane. The decrease of peritoneal exchange capacity is most commonly the reason for termination of peritoneal dialysis.
SGLT2-channels are identified in peritoneal mesothelial cells of rats (Debray-Carcia 2016), and most recently also in humans (Shentu2021). An in vitro model of human peritoneal mesothelial cells incubated with the SGLT2-inhibitor (empagliflozin) has shown significantly decrease in glucose uptake (Zhou2019). Exposure to intraperitoneal empagliflozin in rats, reduced the uptake of glucose over the peritoneal membrane significantly by 78 % and the ultrafiltration was increased (Zhou2019).
Currently, to our knowledge, no clinical trials have been conducted in humans attending peritoneal dialysis with the aim of investigating either the effect or safety of SGLT2i, as it is indeed the first of its kind, with the aim of including participants in peritoneal dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross-over. Off-On-Off treatment. Dose response
| Arm | Type | Receives |
|---|---|---|
| On treatment | Other | Drug: Dapagliflozin 10 MG [Farxiga]Assigned to oral treatment with dapagliflozin 10 mg for three consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Age above 18 years of age
- In stable peritoneal dialysis for more than 14 days.
Key exclusion criteria (11 listed)
- In treatment with SGLT2i currently or within the last 90 days.
- Treatment for peritoneal infection within the last 30 days.
- Any hospitalization within the last 30 days.
- Anaphylaxis to the IMP.
- Impaired lever function with ALAT above normal range within the last 6 month.
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 |
|---|---|---|
| Dapagliflozin 10 MG [Farxiga]Primary end-points are measure before (day 0), on treatment (day 1 and day 3) and after treatment (day 21) | Drug | On treatment |
Primary outcome
Peritoneal glucose uptake (mg/ dL)
Time frame: Day 0 (baseline), Day 3 (max dose of treatment)
Glucose level in peritoneal fluid during a four hour standardized peritoneal dialysis. Change in total glucose uptake before and after treatment (treatment periode of three days)
4 secondary outcomes
Fluid volume (ml)
Time frame: Measured at end of each peritoneal dialysis. Peritoneal dialysis done af Day 0, Day 1 (first day of treatment) and day 3 (max dose of treatment)
Plasma glucose level (mg/ dL)
Time frame: Measured at end of each peritoneal dialysis. Peritoneal dialysis done af Day 0, Day 1 (first day of treatment) and day 3 (max dose of treatment).
Pharmacokinetics (nmol)
Time frame: Samples for biobank - samples drawn at end of each peritoneal dialysis. Peritoneal dialysis done af Day 0, Day 1 (first day of treatment) and day 3 (max dose of treatment). Samples are drawn every 30 minuttes during each peritoneal dialysis.
Adverse events (events)
Time frame: At day 1 (first day of treatment), day 3 (max dose of treatment) and day 30 (four weeks after treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: Yes. The data material used in this study are available from the corresponding author on reasonable request which will not conflict with the anonymity and confidentiality of the data.
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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.
Morten Lindhardt, MD, PhD principal investigator
Copenhagen University Hospital - Holbaek
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 Dapagliflozin 10 MG [Farxiga] in people with End Stage Renal Disease and Peritoneal Dialysis Complication, run by Holbaek Sygehus at 1 site in Denmark.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. 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 Denmark. 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 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?
Results are not available in the source record.
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?
Peritoneal glucose uptake (mg/ dL) (time frame: Day 0 (baseline), Day 3 (max dose of treatment)). 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 22 Feb 2022.