Chronic Kidney DiseaseOPTIMISE-CKDNCT05932901
OPTIMISE-CKD Drug Utilization
An observational study of Chronic Kidney Disease, run by AstraZeneca at 5 sites in 3 countries.
Trial summary
This is a multi-national, observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 2,682,052 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 4 May 2022to 28 Sep 2023
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The overall study population will consist of adult (aged > 18 years) patients with CKD
Who may be able to join
- Adult patients (aged ≥18 years)
- Chronic kidney disease (diagnosis code, uACR >30mg/g or 2 eGFR ≥90 days apart, second value ≥75ml/min/1.73m2)
- ≥365 days continuous enrolment in database
Who cannot join
- History of type 1 diabetes, gestational diabetes or dialysis
- History of dapagliflozin 10mg prescriptions before index date
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
About this study
Official title: A Multinational, Observational, Secondary Data Study Describing Management and Treatment With Dapagliflozin in Routine Clinical Practice Among Patients With Chronic Kidney Disease
This is a multi-national, observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).
Read the detailed description
OPTIMISE-CKD is an observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).
Primary objective: to characterize dapagliflozin 10mg utilisation in clinical practice, by describing treatment naïve patients who (1) are treated with dapagliflozin 10 mg and (2) who are eligible for CKD treatment with dapagliflozin but untreated.
Secondary objectives: to describe the current clinical landscape among incident CKD patients, by:
- Describing baseline demographic and clinical characteristics, drug utilization, and CKD treatment (RAASi and dapagliflozin 10 mg) patterns; and
- Describing selected outcomes among overall, treated and untreated incident CKD patients.
Exploratory objectives: to assess the real-world effectiveness of dapagliflozin in CKD patients, pending feasibility.
- Conditions
- Chronic Kidney Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10mg initiators | Adult patients (aged ≥18 years) with chronic kidney disease, who received a dapagliflozin 10mg prescription on or after the country-specific CKD indication approval date, and who did not previously have a prescription for dapagliflozin. | |
| Dapagliflozin 10mg eligible but untreated | Adult patients (aged ≥18 years) with chronic kidney disease, who meet the country-specific approved dapagliflozin 10mg treatment criteria for CKD on or after the local CKD indication approval date, but have not received a prescription | |
| Incident CKD | Adults patients (aged ≥18 years) who newly meet the CKD definition (diagnosis or laboratory indication) during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline demographics
Patient demographic characteristics including age, sex, race and insurance type (if data are available)
Measured: 1 year pre-index
Baseline clinical characteristics
Number and proportion of patients with comorbidities, including heart failure, cardiovascular disease, type 2 diabetes, hypertension, hyperkalemia, myocardial infarction, stroke
Measured: 1 year pre-index
Baseline comedications
Number and proportion of patients with comedications for cardiovascular disease, diabetes, hyperkalemia
Measured: 1 year pre-index
Baseline eGFR in ml/min/1.73m2
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Measured: 1 year pre-index
Baseline uACR in mg/g
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Measured: 1 year pre-index
Baseline serum creatinine in mg/dl
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Measured: 1 year pre-index
Baseline calcium in mg/dl
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Measured: 1 year pre-index
Baseline sodium in mmol/L
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Measured: 1 year pre-index
Baseline hemoglobin A1c in %
Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum
Measured: 1 year pre-index
Baseline hematocrit in %
Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum, % patients with value <40
Measured: 1 year pre-index
Baseline systolic blood pressure in mmHg
Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum
Measured: 1 year pre-index
Secondary outcomes (4)
Proportion of patients who initiate cardiorenal protective medication
Treatment initiation (RASi and/or SGLT2i/dapagliflozin 10mg) following incident CKD index date
Measured: 1 year post-index
Proportion of patients who continue cardiorenal protective medication
Treatment persistence (RASi and/or SGLT2i/dapagliflozin 10mg) following initiation after incident CKD index date
Measured: 1 year post-index
Proportion of patients with hospitalisations following incident CKD index
Hospitalisations (any reason, CKD, heart failure) following incident CKD index
Measured: 1 year post-index
Average healthcare cost for specific outcomes/reasons
Healthcare costs related to hospitalisation for CKD, heart failure, atherosclerotic CVD following incident CKD index
Measured: 1 year post-index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start4 May 2022
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
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 AstraZenecaThe 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
- 2,682,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932901
- Sponsor's protocol ID
- D169AR00015
- Acronym
- OPTIMISE-CKD
- Status last verified
- Apr 2024
- First submitted
- 5 May 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Observational, Secondary Data Study Describing Management and Treatment With Dapagliflozin in Routine Clinical Practice Among Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05932901
- Acronym / sponsor ID
- OPTIMISE-CKD / D169AR00015
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,682,052 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 May 2022 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 6 Jul 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 a multi-national, observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).
Detailed description
OPTIMISE-CKD is an observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).
Primary objective: to characterize dapagliflozin 10mg utilisation in clinical practice, by describing treatment naïve patients who (1) are treated with dapagliflozin 10 mg and (2) who are eligible for CKD treatment with dapagliflozin but untreated.
Secondary objectives: to describe the current clinical landscape among incident CKD patients, by:
- Describing baseline demographic and clinical characteristics, drug utilization, and CKD treatment (RAASi and dapagliflozin 10 mg) patterns; and
- Describing selected outcomes among overall, treated and untreated incident CKD patients.
Exploratory objectives: to assess the real-world effectiveness of dapagliflozin in CKD patients, pending feasibility.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10mg initiators | – | –Adult patients (aged ≥18 years) with chronic kidney disease, who received a dapagliflozin 10mg prescription on or after the country-specific CKD indication approval date, and who did not previously have a prescription for dapagliflozin. |
| Dapagliflozin 10mg eligible but untreated | – | –Adult patients (aged ≥18 years) with chronic kidney disease, who meet the country-specific approved dapagliflozin 10mg treatment criteria for CKD on or after the local CKD indication approval date, but have not received a prescription |
| Incident CKD | – | –Adults patients (aged ≥18 years) who newly meet the CKD definition (diagnosis or laboratory indication) during the study period. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The overall study population will consist of adult (aged > 18 years) patients with CKD
Key inclusion criteria (3 listed)
- Adult patients (aged ≥18 years)
- Chronic kidney disease (diagnosis code, uACR >30mg/g or 2 eGFR ≥90 days apart, second value ≥75ml/min/1.73m2)
- ≥365 days continuous enrolment in database
Key exclusion criteria (2 listed)
- History of type 1 diabetes, gestational diabetes or dialysis
- History of dapagliflozin 10mg prescriptions before index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline demographics
Time frame: 1 year pre-index
Patient demographic characteristics including age, sex, race and insurance type (if data are available)
Baseline clinical characteristics
Time frame: 1 year pre-index
Number and proportion of patients with comorbidities, including heart failure, cardiovascular disease, type 2 diabetes, hypertension, hyperkalemia, myocardial infarction, stroke
Baseline comedications
Time frame: 1 year pre-index
Number and proportion of patients with comedications for cardiovascular disease, diabetes, hyperkalemia
Baseline eGFR in ml/min/1.73m2
Time frame: 1 year pre-index
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline uACR in mg/g
Time frame: 1 year pre-index
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline serum creatinine in mg/dl
Time frame: 1 year pre-index
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline calcium in mg/dl
Time frame: 1 year pre-index
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline sodium in mmol/L
Time frame: 1 year pre-index
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline hemoglobin A1c in %
Time frame: 1 year pre-index
Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum
Baseline hematocrit in %
Time frame: 1 year pre-index
Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum, % patients with value <40
Baseline systolic blood pressure in mmHg
Time frame: 1 year pre-index
Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum
4 secondary outcomes
Proportion of patients who initiate cardiorenal protective medication
Time frame: 1 year post-index
Proportion of patients who continue cardiorenal protective medication
Time frame: 1 year post-index
Proportion of patients with hospitalisations following incident CKD index
Time frame: 1 year post-index
Average healthcare cost for specific outcomes/reasons
Time frame: 1 year post-index
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 Apr 2024.
- redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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.
5 sites in 3 countries: 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 AstraZeneca at 5 sites in 3 countries.
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 3 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan, Sweden, United States. 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?
Baseline demographics (time frame: 1 year pre-index). The study lists 11 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 Apr 2024.