Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635499
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
VITALIZEUse and Effectiveness of Sodium Zirconium Cyclosilicate LokelmaTM in the Real-world Setting in Spain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Non-interVentional multI-center and longiTudinAL Study to Describe the Use of SodIum Zirconium CyclosilicatE LokelmaTM in Patients Diagnosed With Hyperkalemia in the Real-world Setting in Spain VITALIZE Study
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:
VITALIZE
Brief Summary:
Primary Objectives Hypothesises
1 To describe the status of kalaemia in patients treated with SZC in the real-world setting at first visit after treatment initiation
2 To describe the usual HK management after treatment initiation with SZC in the real-world setting
Secondary Objectives Hypothesises
1 To describe treatment patterns of patients treated with SZC in the real-world setting as well as the SZC treatment duration
2 To describe baseline sociodemographic and clinical characteristics of patients treated with SZC in the real-world setting
3 To describe the evolution of kalaemia and other clinical parameters as well as mortality in patients treated with SZC in the real-world setting
4 To describe Healthcare Resource Utilization HCRU before and after SZC initiation in patients treated with SZC in the real-world setting
5 To analyse specific characteristics of use of SZC in the real-world setting according to the medical specialties
For that purpose a non-interventional multicenter longitudinal study with secondary data collection has been designed involving 20 Spanish public hospitals ans aiming to include 230 patients 10-12 patients per site has been designed
1 To describe the status of kalaemia in patients treated with SZC in the real-world setting at first visit after treatment initiation
2 To describe the usual HK management after treatment initiation with SZC in the real-world setting
Secondary Objectives Hypothesises
1 To describe treatment patterns of patients treated with SZC in the real-world setting as well as the SZC treatment duration
2 To describe baseline sociodemographic and clinical characteristics of patients treated with SZC in the real-world setting
3 To describe the evolution of kalaemia and other clinical parameters as well as mortality in patients treated with SZC in the real-world setting
4 To describe Healthcare Resource Utilization HCRU before and after SZC initiation in patients treated with SZC in the real-world setting
5 To analyse specific characteristics of use of SZC in the real-world setting according to the medical specialties
For that purpose a non-interventional multicenter longitudinal study with secondary data collection has been designed involving 20 Spanish public hospitals ans aiming to include 230 patients 10-12 patients per site has been designed
Detailed Description:
Potassium metabolism disorders are among the most frequent electrolyte disturbances in clinical practice with a spectrum of variable severity A normal potassium level is critical for proper muscle heart and nerve function An excessive level of potassium can cause abnormal heart rhythms and interfere with the functioning of skeletal muscles
Hyperkalaemia is defined by a serum potassium concentration above the upper limit of normal K 5 or 55 mEqL according to guidelines It is considered mild when the potassium concentrations are between 5 to 55 mEqL moderate between 55 and 6 mEqL and severe if potassium concentrations are higher than 6 mEqL Hyperkalaemia is the most serious electrolyte disturbance because it can cause fatal ventricular arrhythmias in minutes
In a recent meta-analysis the pooled prevalence of hyperkalaemia by any definitionthreshold in all adult patients was 63 95CI 58-68 with an incidence of 28 cases per 100 person years while prevalence and incidence were lower in the general population 13 95CI 10-18 and 04 per 100 person years respectively also found that the prevalence was 75 in non-dialysis CKD 83 in diabetes 80 in heart failure and 35 in dialysis-dependent CKD demonstrating that hyperkalaemia risk is influenced by the presence or absence of underlying comorbid conditions The incidence of hyperkalaemia also increases in the elderly population treated with drugs that induce hyperkalaemia such as renin-angiotensin-aldosterone system inhibitors RAASi angiotensin-converting enzyme inhibitors ACEi angiotensin receptor blockers ARBs renin inhibitors mineralocorticoid receptor antagonists MRA or potassium-sparing diuretics
Sodium Zirconium Cyclosilicate SZC commercialized as LokelmaTM is a potassium binder indicated to treat hyperkalaemia constituted by two treatment phases an initial correction phase 10 g3 times dailyoral which is followed by a maintenance phase once patients reach normokalaemia after 24-48h 5gonce daily LokelmaTM was approved by the European Medicines Agency EMA in March 2018 and was launched in Spain in Q2 2021 after having demonstrated its efficacy and safety in different populations doses and timelines in several clinical trials
With the aim of giving greater support to these results and above all in the context of the Spanish population complementary data are needed to understand to what extent the broad group of patients in usual clinical practice achieve normokalaemia and maintain it over the study period after initiation with LokelmaTM The projects goal is to generate real world evidence about the use and the effectiveness of SZC LokelmaTM in Spain through a retrospective Non- Interventional Study NIS
Primary Objectives Hypothesises
1 To describe the status of kalaemia in patients treated with SZC in the real-world setting at first visit after treatment initiation
2 To describe the usual HK management after treatment initiation with SZC in the real-world setting
Secondary Objectives Hypothesises
1 To describe treatment patterns of patients treated with SZC in the real-world setting as well as the SZC treatment duration
2 To describe baseline sociodemographic and clinical characteristics of patients treated with SZC in the real-world setting
3 To describe the evolution of kalaemia and other clinical parameters as well as mortality in patients treated with SZC in the real-world setting
4 To describe Healthcare Resource Utilization HCRU before and after SZC initiation in patients treated with SZC in the real-world setting
5 To analyse specific characteristics of use of SZC in the real-world setting according to the medical specialties
Exploratory Objectives Hypothesises 1 To describe the characteristics of the SZC responder patient according to potassium levels at first visit
Safety Objectives Hypothesises
1 To describe adverse events in patients treated with SZC in the real-world setting
Hyperkalaemia is defined by a serum potassium concentration above the upper limit of normal K 5 or 55 mEqL according to guidelines It is considered mild when the potassium concentrations are between 5 to 55 mEqL moderate between 55 and 6 mEqL and severe if potassium concentrations are higher than 6 mEqL Hyperkalaemia is the most serious electrolyte disturbance because it can cause fatal ventricular arrhythmias in minutes
In a recent meta-analysis the pooled prevalence of hyperkalaemia by any definitionthreshold in all adult patients was 63 95CI 58-68 with an incidence of 28 cases per 100 person years while prevalence and incidence were lower in the general population 13 95CI 10-18 and 04 per 100 person years respectively also found that the prevalence was 75 in non-dialysis CKD 83 in diabetes 80 in heart failure and 35 in dialysis-dependent CKD demonstrating that hyperkalaemia risk is influenced by the presence or absence of underlying comorbid conditions The incidence of hyperkalaemia also increases in the elderly population treated with drugs that induce hyperkalaemia such as renin-angiotensin-aldosterone system inhibitors RAASi angiotensin-converting enzyme inhibitors ACEi angiotensin receptor blockers ARBs renin inhibitors mineralocorticoid receptor antagonists MRA or potassium-sparing diuretics
Sodium Zirconium Cyclosilicate SZC commercialized as LokelmaTM is a potassium binder indicated to treat hyperkalaemia constituted by two treatment phases an initial correction phase 10 g3 times dailyoral which is followed by a maintenance phase once patients reach normokalaemia after 24-48h 5gonce daily LokelmaTM was approved by the European Medicines Agency EMA in March 2018 and was launched in Spain in Q2 2021 after having demonstrated its efficacy and safety in different populations doses and timelines in several clinical trials
With the aim of giving greater support to these results and above all in the context of the Spanish population complementary data are needed to understand to what extent the broad group of patients in usual clinical practice achieve normokalaemia and maintain it over the study period after initiation with LokelmaTM The projects goal is to generate real world evidence about the use and the effectiveness of SZC LokelmaTM in Spain through a retrospective Non- Interventional Study NIS
Primary Objectives Hypothesises
1 To describe the status of kalaemia in patients treated with SZC in the real-world setting at first visit after treatment initiation
2 To describe the usual HK management after treatment initiation with SZC in the real-world setting
Secondary Objectives Hypothesises
1 To describe treatment patterns of patients treated with SZC in the real-world setting as well as the SZC treatment duration
2 To describe baseline sociodemographic and clinical characteristics of patients treated with SZC in the real-world setting
3 To describe the evolution of kalaemia and other clinical parameters as well as mortality in patients treated with SZC in the real-world setting
4 To describe Healthcare Resource Utilization HCRU before and after SZC initiation in patients treated with SZC in the real-world setting
5 To analyse specific characteristics of use of SZC in the real-world setting according to the medical specialties
Exploratory Objectives Hypothesises 1 To describe the characteristics of the SZC responder patient according to potassium levels at first visit
Safety Objectives Hypothesises
1 To describe adverse events in patients treated with SZC in the real-world setting
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