Chronic Kidney Disease in Type 2 DiabetesNCT04445181
A Study Using the LMC Diabetes Registry to Learn More About Chronic Kidney Disease (CKD) in Canadian Patients With Type 2 Diabetes (T2D)
An observational study of Chronic Kidney Disease in Type 2 Diabetes, run by Bayer at 1 site in Canada.
Trial summary
In people with type 2 diabetes (T2D), the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels. People with T2D are at a higher risk of having a condition called chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease in Type 2 Diabetes
- What is being tested?
- The physician's prescription in routine clinical practice
- How many people
- 14,873 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2020to 23 Nov 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include active LMC patients with T2D. This population will be used to determine the prevalence of CKD in patients with T2D. Patients identified with T2D and CKD will form the cohort for all subsequent analysis.
Who may be able to join
- Clinical diagnosis of T2D as captured in the LMC EMR system
- Assessed by an LMC endocrinologist between January 1, 2019 and December 31, 2019
- Followed by an LMC endocrinologist for ≥ 6 months prior to inclusion in the cohort
- Informed consent to use patient medical record data for research purposes was provided
- Among patients who meet the inclusion criteria, estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m^2 and/or urine albumin-to-creatinine ratio (uACR) ≥ 2 mg/mmol will be used to identify the cohort of patients with T2D and CKD
Who cannot join
- Any patients with documented non-diabetic etiology for renal disease will be excluded from the numerator (number of patients with CKD and T2D) when determining the primary endpoint
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study
In people with type 2 diabetes (T2D), the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.
People with T2D are at a higher risk of having a condition called chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. People with CKD can have trouble breathing and often have swelling in their arms and legs, and high blood pressure.
Read more
People who have CKD and T2D are more likely to have other medical problems, such as heart disease.
There are many treatments available to patients who have CKD and T2D. But, researchers need more information about how doctors in Canada are deciding which treatment to give these patients.
In this study, the researchers will review health information from men and women with T2D who visited a doctor in 2019 and had check-ups for at least 6 months. The health information will be taken from a Canadian registry (or database) owned by LMC Diabetes \& Endocrinology. The registry contains information from people that went to an LMC clinic. In this study, the researchers will learn how many of these people had T2D and CKD. They will learn the treatments these people received, and if they had other related medical problems. The researchers will also use surveys to ask the doctors about why they chose certain treatments.
- Being tested
- The physician's prescription in routine clinical practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The physician's prescription in routine clinical practiceDrug
This is an Observational study that will not involve prescription of the drugs.
| Study group | Role | What they receive |
|---|---|---|
| Patients with T2D | Active patients (defined as patients seen by an LMC endocrinologist between January 1, 2019 and December 31, 2019) with T2D (Type 2 Diabetes). Among the patients with T2D, those identified with CKD will be included in the renal registry. Receives: Drug: The physician's prescription in routine clinical practice | |
| Healthcare providers | Healthcare providers caring for patients with CKD and T2D. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with CKD in a large T2D population
The data will be retrieved from the LMC Diabetes Registry, a Pan-Canadian registry of diabetes community-based specialist practices and used to develop a renal registry to investigate the primary objectives of the study
Measured: Retrospectively analysis between January 1, 2019 and December 31, 2019
Secondary outcomes (10)
Proportion of patients using the different therapies
The therapies are: ACEi, ARBs, ACEi/ARBs, MRAs, GLP-1 RA and SGLT2i
Measured: Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients with stage 1 CKD with moderate or greater albuminuria, stage 2 CKD with moderate or greater albuminuria, stage 3a CKD, stage 3b CKD, stage 4 CKD and stage 5 CKD in accordance with Canadian clinical practice guidelines
Stage 1 CKD: eGFR (estimated glomerular filtration rate) ≥ 90 ml/min/1.73 m^2 Stage 2 CKD: eGFR between 60-89 ml/min/1.73 m^2 Stage 3a CKD: eGFR between 45-59 ml/min/1.73 m^2 Stage 3b CKD: eGFR between 30-44 ml/min/1.73 m^2 Stage 4 CKD: eGFR between 15-29 ml/min/1.73 m^2 Stage 5 CKD: eGFR <15 ml/min/1.73 m^2
Measured: Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelines
Microalbuminuria: uACR (urine albumin-to-creatinine ratio) 2-20 mg/mmol Macroalbuminuria: uACR > 20 mg/mmol
Measured: Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelines
KDIGO = Kidney Disease: Improving Global Outcomes
Measured: Retrospectively analysis between January 1, 2019 and December 31, 2019
Laboratory values for patients using either no therapy or using a therapy for ≥ 6 months
Laboratory values including glucose, glycated hemoglobin (HbA1c), lipids, creatinine, electrolytes, eGFR, and uACR
Measured: Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients with different comorbidities
Comorbidities like hypertension, dyslipidemia, microvascular disease, macrovascular disease
Measured: Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of healthcare provider prescriptions of RAS therapies (ACEi/ARB) used to treat hypertension, heart failure, coronary artery disease, CKD, or other condition
RAS: renin angiotensin system ACEi: angiotensin converting enzyme inhibitors ARB: angiotensin receptor blocker
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D
Measured: On the day of healthcare provider completes a questionnaire
Proportion of healthcare provider prescriptions of GLP-1 RA used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition
GLP-1 RA: glucagon-like peptide-1 receptor agonist
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D
Measured: On the day of healthcare provider completes a questionnaire
Proportion of healthcare provider prescriptions of MRAs used to treat hypertension, heart failure, coronary artery disease, CKD or other condition
MRAs: mineralocorticoid receptor antagonists
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D
Measured: On the day of healthcare provider completes a questionnaire
Proportion of healthcare provider prescriptions of SGLT2i used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition
SGLT2i: sodium-glucose co-transporter-2 inhibitors
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D
Measured: On the day of healthcare provider completes a questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Jul 2020
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease in Type 2 DiabetesStudies 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
- 14,873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445181
- Sponsor's protocol ID
- 21190
- Status last verified
- Sep 2021
- First submitted
- 21 Jun 2020
- Last updated
- 5 Oct 2021
- 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.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.
Publications
Chu L, Fuller M, Jervis K, Ciaccia A, Abitbol A. Prevalence of Chronic Kidney Disease in Type 2 Diabetes: The Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study. Clin Ther. 2021 Sep;43(9):1558-1573. doi: 10.1016/j.clinthera.2021.07.015. Epub 2021 Aug 21.
PubMed 34426012
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study
- ClinicalTrials.gov ID
- NCT04445181
- Acronym / sponsor ID
- 21190
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,873 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 24 Jun 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 people with type 2 diabetes (T2D), the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.
People with T2D are at a higher risk of having a condition called chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. People with CKD can have trouble breathing and often have swelling in their arms and legs, and high blood pressure.
People who have CKD and T2D are more likely to have other medical problems, such as heart disease.
There are many treatments available to patients who have CKD and T2D. But, researchers need more information about how doctors in Canada are deciding which treatment to give these patients.
In this study, the researchers will review health information from men and women with T2D who visited a doctor in 2019 and had check-ups for at least 6 months. The health information will be taken from a Canadian registry (or database) owned by LMC Diabetes \& Endocrinology. The registry contains information from people that went to an LMC clinic. In this study, the researchers will learn how many of these people had T2D and CKD. They will learn the treatments these people received, and if they had other related medical problems. The researchers will also use surveys to ask the doctors about why they chose certain treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with T2D | – | Drug: The physician's prescription in routine clinical practiceActive patients (defined as patients seen by an LMC endocrinologist between January 1, 2019 and December 31, 2019) with T2D (Type 2 Diabetes). Among the patients with T2D, those identified with CKD will be included in the renal registry. |
| Healthcare providers | – | –Healthcare providers caring for patients with CKD and T2D. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include active LMC patients with T2D. This population will be used to determine the prevalence of CKD in patients with T2D. Patients identified with T2D and CKD will form the cohort for all subsequent analysis.
Key inclusion criteria (5 listed)
- Clinical diagnosis of T2D as captured in the LMC EMR system
- Assessed by an LMC endocrinologist between January 1, 2019 and December 31, 2019
- Followed by an LMC endocrinologist for ≥ 6 months prior to inclusion in the cohort
- Informed consent to use patient medical record data for research purposes was provided
- Among patients who meet the inclusion criteria, estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m^2 and/or urine albumin-to-creatinine ratio (uACR) ≥ 2 mg/mmol will be used to identify the cohort of patients with T2D and CKD
Key exclusion criteria (1 listed)
- Any patients with documented non-diabetic etiology for renal disease will be excluded from the numerator (number of patients with CKD and T2D) when determining the primary endpoint
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 |
|---|---|---|
| The physician's prescription in routine clinical practiceThis is an Observational study that will not involve prescription of the drugs. | Drug | Patients with T2D |
Primary outcome
Proportion of patients with CKD in a large T2D population
Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
The data will be retrieved from the LMC Diabetes Registry, a Pan-Canadian registry of diabetes community-based specialist practices and used to develop a renal registry to investigate the primary objectives of the study
10 secondary outcomes
Proportion of patients using the different therapies
Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients with stage 1 CKD with moderate or greater albuminuria, stage 2 CKD with moderate or greater albuminuria, stage 3a CKD, stage 3b CKD, stage 4 CKD and stage 5 CKD in accordance with Canadian clinical practice guidelines
Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelines
Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelines
Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
Laboratory values for patients using either no therapy or using a therapy for ≥ 6 months
Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients with different comorbidities
Time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of healthcare provider prescriptions of RAS therapies (ACEi/ARB) used to treat hypertension, heart failure, coronary artery disease, CKD, or other condition
Time frame: On the day of healthcare provider completes a questionnaire
Proportion of healthcare provider prescriptions of GLP-1 RA used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition
Time frame: On the day of healthcare provider completes a questionnaire
Proportion of healthcare provider prescriptions of MRAs used to treat hypertension, heart failure, coronary artery disease, CKD or other condition
Time frame: On the day of healthcare provider completes a questionnaire
Proportion of healthcare provider prescriptions of SGLT2i used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition
Time frame: On the day of healthcare provider completes a questionnaire
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 5 Oct 2021.
- Derived from this study: PubMed 34426012Chu L, Fuller M, Jervis K, Ciaccia A, Abitbol A. Prevalence of Chronic Kidney Disease in Type 2 Diabetes: The Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study. Clin Ther. 2021 Sep;43(9):1558-1573. doi: 10.1016/j.clinthera.2021.07.015. Epub 2021 Aug 21.
- 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.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 Chronic Kidney Disease in Type 2 Diabetes, 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 5 inclusion and 1 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 5 Oct 2021. 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?
Proportion of patients with CKD in a large T2D population (time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445181, which also lists 1 linked publication.
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 5 Oct 2021.