Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391450
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-04-15
Brief Title:
Study of Empagliflozin in Patients with Autosomal Dominant Polycystic Kidney Disease EMPA-PKD
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
Study of Empagliflozin in Patients with Autosomal Dominant Polycystic Kidney Disease EMPA-PKD
Status:
RECRUITING
Status Verified Date:
2024-10
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:
EMPA-PKD
Brief Summary:
The EMPA-PKD trial is assessing the safety of empagliflozin in patients with rapid progressive ADPKD with and without concomitant tolvaptan use by monitoring kidney growth and the rate of loss of kidney function
Detailed Description:
In autosomal dominant polycystic kidney disease ADPKD formation of cysts in the kidneys causes destruction of functional parenchyma and loss of kidney function which may progress to end-stage kidney disease Tolvaptan is the only drug specifically approved for slowing down the progression of ADPKD Sodium glucose cotransporter 2 inhibitors SGLT2i might provide additional benefits but there is currently no information on safety and outcome effects of SGLT2i in patients with ADPKD as these patients were excluded in the landmark SGLT2i trials In an investigator-initiated double-blind mono-center placebo-controlled randomized clinical trial the EMPA-PKD study is assessing the safety of empagliflozin in patients with rapid progressive ADPKD with and without concomitant tolvaptan use by monitoring kidney growth and the rate of loss of kidney function
44 participants will be randomly allocated 11 to receive a daily dose of either empagliflozin 10 mgday or placebo for 18 months Patients will be stratified according to concomitant tolvaptan use The primary endpoint is progression of cystic kidney growth by monitoring MRI-based changes in total kidney volume and the secondary endpoint is exploring changes in glomerular filtration rate Additional endpoints include adverse events and changes in copeptin levels albuminuria and blood pressure
44 participants will be randomly allocated 11 to receive a daily dose of either empagliflozin 10 mgday or placebo for 18 months Patients will be stratified according to concomitant tolvaptan use The primary endpoint is progression of cystic kidney growth by monitoring MRI-based changes in total kidney volume and the secondary endpoint is exploring changes in glomerular filtration rate Additional endpoints include adverse events and changes in copeptin levels albuminuria and blood pressure
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