| Trial ID: | L1314 |
| Source ID: | NCT05250752
|
| Associated Drug: |
Dapagliflozin 10 Mg [Farxiga]
|
| Title: |
Reduction of Peritoneal Glucose Uptake With Use of SGLT2 in Humans Undergoing Peritoneal Dialysis Treatment
|
| Acronym: |
PRESERVE
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease|Peritoneal Dialysis Complication
|
| Interventions: |
DRUG: Dapagliflozin 10 MG [Farxiga]
|
| Outcome Measures: |
Primary: 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), Day 0 (baseline), Day 3 (max dose of treatment) | Secondary: Fluid volume (ml), Fluid volume ultra-filtrated during peritoneal dialysis., 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 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, 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, At day 1 (first day of treatment), day 3 (max dose of treatment) and day 30 (four weeks after treatment)
|
| Sponsor/Collaborators: |
Sponsor: Holbaek Sygehus
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
10
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-11-18
|
| Completion Date: |
2022-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2022-02-22
|
| Locations: |
University Hospital Copenhagen - Holbaek, Holbæk, Zealand, 4300, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT05250752
|
