Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-24
Brief Title:
Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
Sponsor:
Cantonal Hospital Graubuenden
Organization:
Cantonal Hospital Graubuenden
Study Overview
Official Title:
Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIDIA
Brief 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 The primary outcome is tubular handling of the divalent ions calcium phosphate and magnesium Secondary outcomes include diuresis safety and tolerability
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 amp 7 a phone consultation will assess safety
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 amp 7 a phone consultation will assess safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None