Chronic Kidney DiseaseCKD-NHNCT05914259
An Observational Study to Learn More How Chronic Kidney Disease Gradually Changes Over Time in Adults Using Electronic Healthcare Records (CKD Natural History Study)
An observational study of Chronic Kidney Disease, run by Bayer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 969,394 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2023to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective cohort study to assess the natural history of CKD per each CKD stage using data from Merative Explorys Electronic Medical Record (EMR) dataset in the US.
Who may be able to join
- >18 years of age
- At least 12 months of look back period
- For Diagnosed cohorts - ICD codes for CKD diagnosis
- For Lab based cohorts - Two abnormal lab measures of eGFR or uACR/uPCR using LOINC codes.
- Patients were included if they had the same type of test (Modification of Diet in Renal Disease (MDRD) only, CKD Epidemiology Collaboration (CKD EPI) only, Unspecified only) to estimate eGFR throughout their history because the estimation varies depending on the test used which would affect the CKD staging.
Who cannot join
- Birth year absent.
- Patients without any demographic information were excluded
- Patients with history of ESKD
- For Lab based cohorts:-
- Patients were excluded if they had an incorrect test for eGFR identified by LOINC code for e.g. formula for wrong gender (Females with male MDRD formula) or wrong ethnicity (Blacks with white MDRD formula)
- Patients with mixed types of approaches to calculate eGFR (e.g. MDRD, EPI etc.) in their history were excluded. (<20 patients)
- We exclude lab results if the loinc code specific for ethnicity and gender does not match the patient demographics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natural History of Chronic Kidney Disease in the US Population Using Electronic Healthcare Records
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.
Read more
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- No Intervention
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Following the manner of observational study, no intervention will be provided in the study.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed cohort - CKD Stage 1 | Based on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage 1. Receives: Other: No Intervention | |
| Diagnosed cohort - CKD Stage 2 | Based on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage 2. Receives: Other: No Intervention | |
| Diagnosed cohort - CKD Stage 3 | Based on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage 3. Receives: Other: No Intervention | |
| Diagnosed cohort - CKD Stage 4 | Based on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage 4. Receives: Other: No Intervention | |
| Diagnosed cohort - CKD Stage 5 | Based on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage 5. Receives: Other: No Intervention | |
| Diagnosed cohort - CKD Stage Unspecified | Based on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage Unspecified. Receives: Other: No Intervention | |
| Lab based cohort - CKD Stage 1 | Two abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using Logical Observation Identifiers Names and Codes (LOINC) codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 1. Receives: Other: No Intervention | |
| Lab based cohort - CKD Stage 2 | Two abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 2. Receives: Other: No Intervention | |
| Lab based cohort - CKD Stage 3 overall | Two abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 3 overall. Receives: Other: No Intervention | |
| Lab based cohort - CKD Stage 3a | Two abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 3a. Receives: Other: No Intervention | |
| Lab based cohort - CKD Stage 3b | Two abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 3b. Receives: Other: No Intervention | |
| Lab based cohort - CKD Stage 4 | Two abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 4. Receives: Other: No Intervention | |
| Lab based cohort - CKD Stage 5 | Two abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 5. Receives: Other: No Intervention | |
| Lab based cohort - CKD Stage unspecified | Two abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage unspecified. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosed Cohorts - Change in CKD stage based on ICD codes
Measured: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Lab based Cohorts - Change in KDIFO eGFR stage based on two values and at least one of the values showing an increase or decrease by ≥25% in eGFR from baseline stage
Measured: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Secondary outcomes (5)
Descriptive summary of patient characteristics per Chronic kidney disease (CKD) stage (1-5)
Measured: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Time to Major adverse coronary events (MACE)+ (composite and individual components)
MACE including all-cause mortality and also individual components (Myocardial Infarction/ Acute Coronary Syndrome (MI/ACS), Unstable Angina (UA), Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Intervention (PCI), any stroke, hospitalization for heart failure)
Measured: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Time to End Stage Kidney Disease (ESKD)
ESKD which includes dialysis and kidney transplant.
Measured: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Time to all-cause mortality
Measured: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Time to MACE+ and end-stage kidney disease (ESKD) in patients who progressed or regressed
Measured: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start31 May 2023
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 969,394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914259
- Sponsor's protocol ID
- 22557
- Acronym
- CKD-NH
- Status last verified
- Jul 2024
- First submitted
- 5 Jun 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Chronic Kidney Disease in the US Population Using Electronic Healthcare Records
- ClinicalTrials.gov ID
- NCT05914259
- Acronym / sponsor ID
- CKD-NH / 22557
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 969,394 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 May 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Diagnosed cohort - CKD Stage 1 | – | Other: No InterventionBased on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage 1. |
| Diagnosed cohort - CKD Stage 2 | – | Other: No InterventionBased on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage 2. |
| Diagnosed cohort - CKD Stage 3 | – | Other: No InterventionBased on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage 3. |
| Diagnosed cohort - CKD Stage 4 | – | Other: No InterventionBased on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage 4. |
| Diagnosed cohort - CKD Stage 5 | – | Other: No InterventionBased on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage 5. |
| Diagnosed cohort - CKD Stage Unspecified | – | Other: No InterventionBased on diagnosis codes (International Classification of Diseases (ICD) codes) indicating Stage Unspecified. |
| Lab based cohort - CKD Stage 1 | – | Other: No InterventionTwo abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using Logical Observation Identifiers Names and Codes (LOINC) codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 1. |
| Lab based cohort - CKD Stage 2 | – | Other: No InterventionTwo abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 2. |
| Lab based cohort - CKD Stage 3 overall | – | Other: No InterventionTwo abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 3 overall. |
| Lab based cohort - CKD Stage 3a | – | Other: No InterventionTwo abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 3a. |
| Lab based cohort - CKD Stage 3b | – | Other: No InterventionTwo abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 3b. |
| Lab based cohort - CKD Stage 4 | – | Other: No InterventionTwo abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 4. |
| Lab based cohort - CKD Stage 5 | – | Other: No InterventionTwo abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage 5. |
| Lab based cohort - CKD Stage unspecified | – | Other: No InterventionTwo abnormal lab measures of estimated Glomerular Filtration Rate (eGFR), or Urine Albumin-Creatinine Ratio (uACR)/ Urine Protein Creatinine Ratio (uPCR) using LOINC codes based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines indicating Stage unspecified. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective cohort study to assess the natural history of CKD per each CKD stage using data from Merative Explorys Electronic Medical Record (EMR) dataset in the US.
Key inclusion criteria (5 listed)
- >18 years of age
- At least 12 months of look back period
- For Diagnosed cohorts - ICD codes for CKD diagnosis
- For Lab based cohorts - Two abnormal lab measures of eGFR or uACR/uPCR using LOINC codes.
Key exclusion criteria (7 listed)
- Birth year absent.
- Patients without any demographic information were excluded
- Patients with history of ESKD
- For Lab based cohorts:-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionFollowing the manner of observational study, no intervention will be provided in the study. | Other | Diagnosed cohort - CKD Stage 1, Diagnosed cohort - CKD Stage 2, Diagnosed cohort - CKD Stage 3, Diagnosed cohort - CKD Stage 4, Diagnosed cohort - CKD Stage 5, Diagnosed cohort - CKD Stage Unspecified, Lab based cohort - CKD Stage 1, Lab based cohort - CKD Stage 2, Lab based cohort - CKD Stage 3 overall, Lab based cohort - CKD Stage 3a, Lab based cohort - CKD Stage 3b, Lab based cohort - CKD Stage 4, Lab based cohort - CKD Stage 5, Lab based cohort - CKD Stage unspecified |
Primary outcome
Diagnosed Cohorts - Change in CKD stage based on ICD codes
Time frame: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Lab based Cohorts - Change in KDIFO eGFR stage based on two values and at least one of the values showing an increase or decrease by ≥25% in eGFR from baseline stage
Time frame: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
5 secondary outcomes
Descriptive summary of patient characteristics per Chronic kidney disease (CKD) stage (1-5)
Time frame: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Time to Major adverse coronary events (MACE)+ (composite and individual components)
Time frame: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Time to End Stage Kidney Disease (ESKD)
Time frame: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Time to all-cause mortality
Time frame: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Time to MACE+ and end-stage kidney disease (ESKD) in patients who progressed or regressed
Time frame: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosed Cohorts - Change in CKD stage based on ICD codes (time frame: Retrospective analysis between 1 Jan 2010 to 31 Dec 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.