Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-25 @ 1:19 PM
Study NCT ID:
NCT05914259
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2023-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Study to Learn More How Chronic Kidney Disease Gradually Changes Over Time in Adults Using Electronic Healthcare Records (CKD Natural History Study)
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Natural History of Chronic Kidney Disease in the US Population Using Electronic Healthcare Records
Status:
COMPLETED
Status Verified Date:
2024-07
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:
CKD-NH
Brief Summary:
This is an observational study in which the health data of people with chronic kidney disease are studied using electronic healthcare records. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
Chronic kidney disease (CKD) is a condition in which the kidney's ability to work properly gradually decreases over time. This causes a buildup of waste in the body and can lead to loss of kidney function over the long term. CKD is divided into different stages based on how well the kidneys are filtering the blood.
CKD is known to increase the risk of developing serious health problems such as serious heart problems, irreversible damage to kidneys requiring either dialysis or a kidney transplant (end stage kidney disease, ESKD), and early death. However, there is limited information available about how often heart problems occur in people with different stages of CKD, and how a history of heart problems might affect future risks for CKD patients.
The purpose of this study is to collect more information on how CKD changes over time for people at different CKD stages and how it affects their heart and kidneys.
The main information that researchers will collect in this study:
changes in kidney function (worsening or improvement).
Other information that researchers will collect:
patient characteristics for each stage of CKD,
the length of time for serious heart-related conditions to occur,
the length of time it takes for CKD to progress to kidney failure,
the length of time for occurrence of deaths due to any causes, and
the length of time it takes for serious heart-related conditions and kidney failure to occur.
This study will include CKD patients above 18 years of age. Researchers will review electronic healthcare records to identify CKD patients in two ways:
using disease codes for CKD and
using lab results which show abnormal kidney function.
The data will come from participants' information stored in an electronic healthcare records database called Merative Explorys database Electronic Medical Record (EMR) in the United States of America.
The research will cover the period from January 2010 up to December 2019.
Researchers will track individual patients' data and will follow them for a maximum of 5 years or until they experience certain events like changes to their CKD stage, kidney failure, serious heart-related conditions, or death.
In this study, only available data from routine care is analyzed. No visits or tests are required.
Chronic kidney disease (CKD) is a condition in which the kidney's ability to work properly gradually decreases over time. This causes a buildup of waste in the body and can lead to loss of kidney function over the long term. CKD is divided into different stages based on how well the kidneys are filtering the blood.
CKD is known to increase the risk of developing serious health problems such as serious heart problems, irreversible damage to kidneys requiring either dialysis or a kidney transplant (end stage kidney disease, ESKD), and early death. However, there is limited information available about how often heart problems occur in people with different stages of CKD, and how a history of heart problems might affect future risks for CKD patients.
The purpose of this study is to collect more information on how CKD changes over time for people at different CKD stages and how it affects their heart and kidneys.
The main information that researchers will collect in this study:
changes in kidney function (worsening or improvement).
Other information that researchers will collect:
patient characteristics for each stage of CKD,
the length of time for serious heart-related conditions to occur,
the length of time it takes for CKD to progress to kidney failure,
the length of time for occurrence of deaths due to any causes, and
the length of time it takes for serious heart-related conditions and kidney failure to occur.
This study will include CKD patients above 18 years of age. Researchers will review electronic healthcare records to identify CKD patients in two ways:
using disease codes for CKD and
using lab results which show abnormal kidney function.
The data will come from participants' information stored in an electronic healthcare records database called Merative Explorys database Electronic Medical Record (EMR) in the United States of America.
The research will cover the period from January 2010 up to December 2019.
Researchers will track individual patients' data and will follow them for a maximum of 5 years or until they experience certain events like changes to their CKD stage, kidney failure, serious heart-related conditions, or death.
In this study, only available data from routine care is analyzed. No visits or tests are required.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: