Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653738
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Placebo-controlled Trial to Assess Efficacies of EMPAgliflozin and Personalized Dietary Counselling for Kidney STONE Prevention in Patients With Calcium Kidney Stones Acronym EMPASTONE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPASTONE
Brief Summary:
The aim of this randomized trial with a 2-by-2 factorial design is to test the efficacy of the SGLT2 inhibitor empagliflozin and personalized dietary counseling based on 24-hr urine collection results and dietary assessments for kidney stone recurrence prevention in patients with calcium kidney stones
Study interventions
Empagliflozin 25 mg once daily per os for 36 months
Personalized dietary counseling for 36 months
Control interventions
Placebo once daily per os for 36 months
Generic dietary counseling for 36 months
Study interventions
Empagliflozin 25 mg once daily per os for 36 months
Personalized dietary counseling for 36 months
Control interventions
Placebo once daily per os for 36 months
Generic dietary counseling for 36 months
Detailed Description:
Background
Nephrolithiasis is a highly prevalent kidney disorder that causes substantial morbidity reduced quality of life and enormous healthcare expenditures worldwide Kidney stones recur frequently with 10-year recurrence rates of up to 80 Existing pharmacological strategies for the prevention of kidney stone recurrence are limited and dietary counselling practices for patients with kidney stones vary widely In observational studies and post-hoc analyses of cardiovascular outcome trials sodium-glucose cotransporter 2 inhibitor SGLT2i use was associated with a reduction in kidney stone events in patients with type 2 diabetes In the recent randomized phase 2 trial SWEETSTONE NCT04911660 the SGLT2i empagliflozin significantly improved the urinary lithogenic risk profile compared to placebo in non-diabetic patients with calcium kidney stones by far the most common kidney stone type
Rationale
The efficacy of SGLT2is in the prevention of kidney stone recurrence in patients with kidney stones is unknown Furthermore the optimal dietary counseling approach for individuals with kidney stones remains unclear
Objective
The investigators plan to conduct a 3-year multicentric double-blind placebo-controlled factorial trial to assess the efficacy of empagliflozin with either a personalized or generic dietary counselling strategy for recurrence prevention in patients with calcium kidney stones
Methodology
The investigators will include 380 adult 18 years patients with recurrent 2 kidney stone episodes in the last 10 years calcium kidney stones containing 50 or more of calcium oxalate calcium phosphate or a mixture of both Patients with known secondary causes of kidney stones will be excluded In this randomized trial with a 2-by-2 factorial design patients will be allocated to either empagliflozin 25 mg or placebo once daily and to either personalized or generic dietary counselling according to 24-hr urine results Randomization will be stratified according to the number of kidney stone episodes during the 10 years before enrolment
The primary endpoint will be radiologic kidney stone recurrence a composite of stone growth or new stones formed assessed by computed tomography at 3 years Secondary endpoints will be symptomatic kidney stone recurrence up to 3 years and the number of symptomatic recurrences over 3 years Exploratory endpoints will be changes in blood and urine parameters vital signs and weight asymptomatic kidney stone passage patient-reported pain and quality of life and kidney stone event-related health care utilization and cost Safety endpoints assessed will be the frequency of serious adverse events and of pre-defined adverse events of special interest
Nephrolithiasis is a highly prevalent kidney disorder that causes substantial morbidity reduced quality of life and enormous healthcare expenditures worldwide Kidney stones recur frequently with 10-year recurrence rates of up to 80 Existing pharmacological strategies for the prevention of kidney stone recurrence are limited and dietary counselling practices for patients with kidney stones vary widely In observational studies and post-hoc analyses of cardiovascular outcome trials sodium-glucose cotransporter 2 inhibitor SGLT2i use was associated with a reduction in kidney stone events in patients with type 2 diabetes In the recent randomized phase 2 trial SWEETSTONE NCT04911660 the SGLT2i empagliflozin significantly improved the urinary lithogenic risk profile compared to placebo in non-diabetic patients with calcium kidney stones by far the most common kidney stone type
Rationale
The efficacy of SGLT2is in the prevention of kidney stone recurrence in patients with kidney stones is unknown Furthermore the optimal dietary counseling approach for individuals with kidney stones remains unclear
Objective
The investigators plan to conduct a 3-year multicentric double-blind placebo-controlled factorial trial to assess the efficacy of empagliflozin with either a personalized or generic dietary counselling strategy for recurrence prevention in patients with calcium kidney stones
Methodology
The investigators will include 380 adult 18 years patients with recurrent 2 kidney stone episodes in the last 10 years calcium kidney stones containing 50 or more of calcium oxalate calcium phosphate or a mixture of both Patients with known secondary causes of kidney stones will be excluded In this randomized trial with a 2-by-2 factorial design patients will be allocated to either empagliflozin 25 mg or placebo once daily and to either personalized or generic dietary counselling according to 24-hr urine results Randomization will be stratified according to the number of kidney stone episodes during the 10 years before enrolment
The primary endpoint will be radiologic kidney stone recurrence a composite of stone growth or new stones formed assessed by computed tomography at 3 years Secondary endpoints will be symptomatic kidney stone recurrence up to 3 years and the number of symptomatic recurrences over 3 years Exploratory endpoints will be changes in blood and urine parameters vital signs and weight asymptomatic kidney stone passage patient-reported pain and quality of life and kidney stone event-related health care utilization and cost Safety endpoints assessed will be the frequency of serious adverse events and of pre-defined adverse events of special interest
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None