Renal Insufficiency, ChronicAWARE-CKDNCT04498156
Survey of Patient and Physician Awareness and Values to the Diagnosis and Treatment of Reduced Kidney Function (Chronic Kidney Disease) in Patients With High Blood Sugar Level (Type 2 Diabetes) (AWARE-CKD in T2D)
An observational study of Renal Insufficiency, Chronic, run by Bayer at 1 site in Canada.
Trial summary
In this survey study, researchers want to find out more about how physicians are treating patients diagnosed with reduced kidney function (chronic kidney disease, CKD) and high blood sugar level (type 2 diabetes); what physicians know about the different treatment options available; and how they use this knowledge to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Chronic
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2020to 30 Apr 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with CKD and T2DM and treating general practitioners, endocrinologists, nephrologists in Canada
Who may be able to join
- For patient cohort:
- Diagnosis of type 2 diabetes
- eGFR < 60 ml/min per 1.73 m2 (measured within the last year) OR eGFR ≥ 60 ml/min per 1.73 m2 and uACR ≥ 2 (measured within the last year)
- No documented non-diabetic etiology for renal disease
- For physician cohort:
- Licensed general practitioner, endocrinologist or nephrologist
- Currently providing care for patients with chronic kidney disease and type 2 diabetes
Who cannot join
- Patients with chronic kidney disease and type 2 diabetes who are physicians
- Physicians with chronic kidney disease and type 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Awareness of Diagnosis and Treatment of Chronic Kidney Disease in Patients With Type 2 Diabetes
In this survey study, researchers want to find out more about how physicians are treating patients diagnosed with reduced kidney function (chronic kidney disease, CKD) and high blood sugar level (type 2 diabetes); what physicians know about the different treatment options available; and how they use this knowledge to treat their patients successfully. Additionally, researchers want to gather information about patient's awareness of their disease and which criteria they consider important for their treatment of the disease.
The study will survey a total of 150 patients with type 2 diabetes: 50 patients with mild CKD; 50 patients with moderate CKD; and 50 patients with severe CKD. Patients eligible for this study can be male or female and should be at least 18 years old. In addition, a total of 150 physicians will be surveyed. Physicians eligible for this study may be general practitioners, endocrinologist, or nephrologists.
Read the detailed description
The primary objective in this study is to assess the awareness, values and preferences of patients and physicians with respect to the risks, consequences and management of chronic kidney disease (CKD) in patients with type 2 diabetes.
Secondary objectives aim to assess awareness of available CKD treatments, referral tools and communication between patients and physicians.
Both patients and physicians will complete a survey that consists of various questions regarding the knowledge of disease, values and treatments, patient-physician interaction, physician referral tools and disease risk management.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- No intervention
- Keywords
- Chronic kidney disease (CKD), Type 2 Diabetes (T2D), Patient awareness, Physician awareness, Interaction patient physician
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention, observational study
| Study group | Role | What they receive |
|---|---|---|
| CKD-Patients | Cohort consisting of adult patients with a known diagnosis of type 2 diabetes and evidence of chronic kidney disease (CKD) Receives: Other: No intervention | |
| Physicians treating CKD | Cohort consisting of licensed general practitioners, endocrinologists and nephrologists who are currently treating patients with both chronic kidney disease (CKD) and type 2 diabetes Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of chronic kidney disease in T2D
Awareness will be summarized descriptively based on various survey questions.
Measured: 1 day
Values regarding chronic kidney disease in T2D
Values regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.
Measured: 1 day
Preferences regarding chronic kidney disease in T2D
Preferences regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.
Measured: 1 day
Secondary outcomes (3)
Awareness of available treatments for chronic kidney disease in T2D
Awareness of available treatments will be summarized descriptively based on various survey questions.
Measured: 1 day
Physician awareness of available referral tools for the management of chronic kidney disease in T2D
Physician cohort only. Referral tools may comprise of various standard guidelines (e.g. KidneyWise, KDIGO guidelines, Diabetes Canada guidelines). A higher number of referral tools known by physicians indicates a better awareness of CKD referral tools.
Measured: 1 day
Time point of communicated CKD diagnosis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start16 Sep 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LMC Diabetes & Endocrinology Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498156
- Sponsor's protocol ID
- 21225
- Acronym
- AWARE-CKD
- Status last verified
- Apr 2022
- First submitted
- 31 Jul 2020
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness of Diagnosis and Treatment of Chronic Kidney Disease in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04498156
- Acronym / sponsor ID
- AWARE-CKD / 21225
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Chronic kidney disease (CKD), Type 2 Diabetes (T2D), Patient awareness, Physician awareness, Interaction patient physician
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- LMC Diabetes & Endocrinology Ltd.
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 4 Aug 2020 (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.
In this survey study, researchers want to find out more about how physicians are treating patients diagnosed with reduced kidney function (chronic kidney disease, CKD) and high blood sugar level (type 2 diabetes); what physicians know about the different treatment options available; and how they use this knowledge to treat their patients successfully. Additionally, researchers want to gather information about patient's awareness of their disease and which criteria they consider important for their treatment of the disease.
The study will survey a total of 150 patients with type 2 diabetes: 50 patients with mild CKD; 50 patients with moderate CKD; and 50 patients with severe CKD. Patients eligible for this study can be male or female and should be at least 18 years old. In addition, a total of 150 physicians will be surveyed. Physicians eligible for this study may be general practitioners, endocrinologist, or nephrologists.
Detailed description
The primary objective in this study is to assess the awareness, values and preferences of patients and physicians with respect to the risks, consequences and management of chronic kidney disease (CKD) in patients with type 2 diabetes.
Secondary objectives aim to assess awareness of available CKD treatments, referral tools and communication between patients and physicians.
Both patients and physicians will complete a survey that consists of various questions regarding the knowledge of disease, values and treatments, patient-physician interaction, physician referral tools and disease risk management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD-Patients | – | Other: No interventionCohort consisting of adult patients with a known diagnosis of type 2 diabetes and evidence of chronic kidney disease (CKD) |
| Physicians treating CKD | – | Other: No interventionCohort consisting of licensed general practitioners, endocrinologists and nephrologists who are currently treating patients with both chronic kidney disease (CKD) and type 2 diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CKD and T2DM and treating general practitioners, endocrinologists, nephrologists in Canada
Key inclusion criteria (7 listed)
- For patient cohort:
- For physician cohort:
Key exclusion criteria (2 listed)
- Patients with chronic kidney disease and type 2 diabetes who are physicians
- Physicians with chronic kidney disease and type 2 diabetes
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 interventionNo intervention, observational study | Other | CKD-Patients, Physicians treating CKD |
Primary outcome
Awareness of chronic kidney disease in T2D
Time frame: 1 day
Awareness will be summarized descriptively based on various survey questions.
Values regarding chronic kidney disease in T2D
Time frame: 1 day
Values regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.
Preferences regarding chronic kidney disease in T2D
Time frame: 1 day
Preferences regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.
3 secondary outcomes
Awareness of available treatments for chronic kidney disease in T2D
Time frame: 1 day
Physician awareness of available referral tools for the management of chronic kidney disease in T2D
Time frame: 1 day
Time point of communicated CKD diagnosis
Time frame: 1 day
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 21 Apr 2022.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors 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 Renal Insufficiency, Chronic, run by Bayer at 1 site in Canada.
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 7 inclusion and 2 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 21 Apr 2022. 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 Canada. 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?
Awareness of chronic kidney disease in T2D (time frame: 1 day). The study lists 3 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 21 Apr 2022.