Chronic Kidney DiseaseNCT07450820
OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD
An observational study of Chronic Kidney Disease, run by AstraZeneca at 1 site in Spain.
Trial summary
This is a retrospective, observational study, using secondary data captured in electronic health records (EHRs). The study is a part of the OPTIMISE-CKD program to assess the current CKD treatment landscape, Dapagliflozin utilisation and characterization of incident CKD patient and the burden of disease within an… 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
- 12,894 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2026to 6 May 2026
- 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 at index date) patients with CKD
Who may be able to join
- Meets CKD definition criteria: having at least two eGFR measures ≤60 ml/min/1.73m2 measured ≥90 to 730 days apart and/or UACR ≥ 30 mg/g, and/or at least one measurement indicative of proteinuria (or with proteinuria ERA-ICD code) or CKD code.
- Age ≥18 years.
- 12 months continuous enrolment in the data base prior to index
- 12 months continuous enrolment in the data base after index date.
Who cannot join
- T1DM on or before index date.
- Diagnosis of gestational diabetes mellitus on or before index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multinational, Observational, Retrospective, Secondary Data Study Analyzing Dapagliflozin Effectiveness in Routine Clinical Practice Among Patients With Chronic Kidney Disease. Local Adaptation for Spain. Part 2
This is a retrospective, observational study, using secondary data captured in electronic health records (EHRs). The study is a part of the OPTIMISE-CKD program to assess the current CKD treatment landscape, Dapagliflozin utilisation and characterization of incident CKD patient and the burden of disease within an observation period of 39 months (August 2020-November 2024) in two cohorts (preand post-reimbursement of Dapagliflozin for CKD)
- 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 |
|---|---|---|
| Cohort of patients treated with Dapagliflozin 10 mg | Cohort of patients treated with Dapagliflozin 10 mg. Patients who start treatment with Dapagliflozin after meeting the inclusion criteria. The first prescription of Dapagliflozin 10 mg will be considered as the index date. | |
| Comparator cohort without specific treatment for CKD other than RASi | Patients who do not receive Dapagliflozin, but who meet the inclusion criteria and have RASi as CKD treatment or no specific treatment for CKD other than RASi. The index date will be matched with that of your Dapagliflozin-treated counterpart, within a ±10-day window. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline demographics and clinical characteristics (comorbidities) of the study cohorts
Age (years old) Gender (female, N(%)) Comorbidities (N(%) Cardiovascular comorbidity (ICD code) Type 2 diabetes (ICD code) Hypertension (ICD code)
Measured: From 1-Aug-2021 to 31-Dec-2025
Baseline laboratory measures (number of measures per year and their values)
Measured: From 1-Aug-2021 to 31-Dec-2025
Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs and prescriber characteristics for Dapagliflozin if available).
Measured: From 1-Aug-2021 to 31-Dec-2025
Compare selected outcomes
eGFR decline with time, (difference from baseline value)
Measured: From 1-Aug-2021 to 31-Dec-2025
Compare selected health-care resource utilization and cost
Compare selected health-care resource utilization and cost (resource consumption refers to that which is directly related to CKD): -initiation of dialysis -all-cause hospitalizations -heart failure hospitalizations (hHF) - CKD hospitalizations -primary care visits -hospital specialty visits -emergency visits
Measured: From 1-Aug-2021 to 31-Dec-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start18 Feb 2026
- Primary completion6 May 2026
- Study completion6 May 2026
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
- 12,894 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450820
- Sponsor's protocol ID
- D169AR00037
- Status last verified
- May 2026
- First submitted
- 4 Feb 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Individual data sharing
- No: 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Observational, Retrospective, Secondary Data Study Analyzing Dapagliflozin Effectiveness in Routine Clinical Practice Among Patients With Chronic Kidney Disease. Local Adaptation for Spain. Part 2
- ClinicalTrials.gov ID
- NCT07450820
- Acronym / sponsor ID
- D169AR00037
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,894 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 5 Mar 2026 (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 retrospective, observational study, using secondary data captured in electronic health records (EHRs). The study is a part of the OPTIMISE-CKD program to assess the current CKD treatment landscape, Dapagliflozin utilisation and characterization of incident CKD patient and the burden of disease within an observation period of 39 months (August 2020-November 2024) in two cohorts (preand post-reimbursement of Dapagliflozin for CKD)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort of patients treated with Dapagliflozin 10 mg | – | –Cohort of patients treated with Dapagliflozin 10 mg. Patients who start treatment with Dapagliflozin after meeting the inclusion criteria. The first prescription of Dapagliflozin 10 mg will be considered as the index date. |
| Comparator cohort without specific treatment for CKD other than RASi | – | –Patients who do not receive Dapagliflozin, but who meet the inclusion criteria and have RASi as CKD treatment or no specific treatment for CKD other than RASi. The index date will be matched with that of your Dapagliflozin-treated counterpart, within a ±10-day window. |
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 at index date) patients with CKD
Key inclusion criteria (4 listed)
- Meets CKD definition criteria: having at least two eGFR measures ≤60 ml/min/1.73m2 measured ≥90 to 730 days apart and/or UACR ≥ 30 mg/g, and/or at least one measurement indicative of proteinuria (or with proteinuria ERA-ICD code) or CKD code.
- Age ≥18 years.
- 12 months continuous enrolment in the data base prior to index
- 12 months continuous enrolment in the data base after index date.
Key exclusion criteria (2 listed)
- T1DM on or before index date.
- Diagnosis of gestational diabetes mellitus on or 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 and clinical characteristics (comorbidities) of the study cohorts
Time frame: From 1-Aug-2021 to 31-Dec-2025
Age (years old) Gender (female, N(%)) Comorbidities (N(%) Cardiovascular comorbidity (ICD code) Type 2 diabetes (ICD code) Hypertension (ICD code)
Baseline laboratory measures (number of measures per year and their values)
Time frame: From 1-Aug-2021 to 31-Dec-2025
Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs and prescriber characteristics for Dapagliflozin if available).
Time frame: From 1-Aug-2021 to 31-Dec-2025
Compare selected outcomes
Time frame: From 1-Aug-2021 to 31-Dec-2025
eGFR decline with time, (difference from baseline value)
Compare selected health-care resource utilization and cost
Time frame: From 1-Aug-2021 to 31-Dec-2025
Compare selected health-care resource utilization and cost (resource consumption refers to that which is directly related to CKD): -initiation of dialysis -all-cause hospitalizations -heart failure hospitalizations (hHF) - CKD hospitalizations -primary care visits -hospital specialty visits -emergency visits
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 27 May 2026.
- Individual participant dataSharing planned: No. 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 shared.
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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 AstraZeneca at 1 site in Spain.
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 4 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 27 May 2026. 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 Spain. 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 and clinical characteristics (comorbidities) of the study cohorts (time frame: From 1-Aug-2021 to 31-Dec-2025). The study lists 5 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 27 May 2026.