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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05250752
Other study ID # HOL-MED-01-2021
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date November 18, 2021
Est. completion date December 31, 2022

Study information

Verified date November 2021
Source Holbaek Sygehus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 10
Est. completion date December 31, 2022
Est. primary completion date February 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Written informed consent 2. Age above 18 years of age 3. In stable peritoneal dialysis for more than 14 days. Exclusion Criteria: 1. In treatment with SGLT2i currently or within the last 90 days. 2. Treatment for peritoneal infection within the last 30 days. 3. Any hospitalization within the last 30 days. 4. Anaphylaxis to the IMP. 5. Impaired lever function with ALAT above normal range within the last 6 month. 6. Sever efflux problems during peritoneal dialysis for the last 14 days, judged by the investigator. 7. Non-menopausal defined as menstruation within the last 12 month without any other medical cause. Only applicable for female participants. 8. Substance abuse, judged by the investigator. 9. Incapable to follow study protocol, judged by the investigator. 10. Previously included in this clinical trial and exposed to the IMP. 11. Included in another clinical trial with exposure to any IMP within the last 30 days.

Study Design


Intervention

Drug:
Dapagliflozin 10 MG [Farxiga]
Primary end-points are measure before (day 0), on treatment (day 1 and day 3) and after treatment (day 21)

Locations

Country Name City State
Denmark University Hospital Copenhagen - Holbaek Holbæk Zealand

Sponsors (1)

Lead Sponsor Collaborator
Holbaek Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
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)
Secondary 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).
Secondary 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.
Secondary 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)
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