Status:
UNKNOWN
Reduction of Peritoneal Glucose Uptake With Use of SGLT2 in Humans Undergoing Peritoneal Dialysis Treatment
Lead Sponsor:
Holbaek Sygehus
Conditions:
End Stage Renal Disease
Peritoneal Dialysis Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pati...
Eligibility Criteria
Inclusion
- Written informed consent
- Age above 18 years of age
- In stable peritoneal dialysis for more than 14 days.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
November 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05250752
Start Date
November 18 2021
End Date
December 31 2022
Last Update
February 22 2022
Active Locations (1)
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1
University Hospital Copenhagen - Holbaek
Holbæk, Region Sjælland, Denmark, 4300