Renal DiseaseNCT06614712
OPTIMISE-CKD Study_current Clinical Landscape in Spain
An observational study of Renal Disease, run by AstraZeneca at 1 site in Spain.
Trial summary
OPTIMISE-CKD is a retrospective, observational study, using secondary data. The incidence of renal disease, including CKD, using eGFR or UACR laboratory measurements and diagnostic codes will be assessed in the study population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease
- What is being tested?
- Pre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024) and Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024)
- How many people
- 91,628 participants
- Where
- 1 siteSpain
- Study dates
- 4 Dec 2024to 6 Oct 2025
- 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: The overall study population will consist of adult patients, aged ≥18 years as of study index date, with their renal function measured
Who may be able to join
- Age ≥18 years as of study index date
- With renal function measured as either of the following:
- At least 1 UACR measure of ≥30 mg/g; OR
- At least 2 eGFR measures taken ≥90 days apart, of which both eGFR is ≤75 ml/min/1.73m2 ; OR
- registered with Chronic Kidney Disease (CKD) diagnosis in the medical history (without biochemical confirmation)
Who cannot join
- History of stage 5 CKD, dialysis, organ transplant, type 1 diabetes, or gestational diabetes on or before the start date of the observation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multinational, Observational, Retrospective, Secondary Data Study Describing Management and Treatment in Routine Clinical Practice Among Patients With Chronic Kidney Disease. Local Adaptation for Spain. Part 1
OPTIMISE-CKD is a retrospective, observational study, using secondary data. The incidence of renal disease, including CKD, using eGFR or UACR laboratory measurements and diagnostic codes will be assessed in the study population. The study will also assess the incidence of selected cardiovascular and renal events and the current use of kidney-protective treatments
- Conditions
- Renal Disease
- Being tested
- Pre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024), Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024)
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024)Other
Incident renal disease patients in this cohort are defined as those that newly met the renal function measurement definition stated above, with first-ever registered laboratory UACR and/or eGFR measurements or CKD diagnosis on or after the start date of this cohort study period, the 1st August 2020 and until the 1 st February 2023 (DAPA_CKD P\&R date in Spain). The first of the dates fulfilling any of the criteria defined above for the renal function measurement or CKD diagnosis, is defined as the patient index date-1 of this study cohort.
At the index date-1, the renal disease will be staged based on eGFR (and/or UACR measurements in addition, if available) as specified in the KDIGO guidelines.
Patients will be followed up from the index date-1 until the end of continuous enrolment, last date of available data or date of death, until the end of the overall observation period.
Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024)Other
We define the post-P\&R cohort including all incident renal disease patients observed in the dapagliflozin-CKD post-pricing and reimbursement period. Patients in this cohort newly met the renal function measurement definition stated above, with first-ever registered laboratory UACR and/or eGFR measurements or CKD diagnosis on or after the 1 st February 2023 (DAPA_CKD P\&R date in Spain) and until the end of the study observation period. The first of the dates fulfilling any of the criteria defined above for the renal function measurement or CKD diagnosis, is defined as the patient index date-2 of this study cohort. At the index date-2, the renal disease will be staged based on eGFR (and/or UACR measurements in addition, if available) as specified in the KDIGO guidelines. Patients will be followed up from the index date-2 until the end of continuous enrolment, last date of available data or date of death, until the end of the overall study period
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Pre-pricing \& reimbursement, incident renal disease cohort (study observation period 2020- 2024) Receives: Other: Pre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024) | |
| Cohort 2 | Post-pricing \& reimbursement, incident renal disease cohort (study observation period 2023-2024) Receives: Other: Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline demographics and clinical characteristics of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Measured: from the 1st August 2020 to 30th September 2024
Baseline laboratory measures (number of measures per year and their values) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Measured: from the 1st August 2020 to 30th September 2024
Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Measured: Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Initiation of kidney-protective treatment (RAASi or SGLT2i or both) among treatment naïve patients in the pre-P&R cohort and post- P&R
Measured: from the 1st August 2020 to 30th September 2024
Discontinuation of newly initiated RAASi or SGLT-2i treatment in the two cohorts of the study, pre-P&R and post-P&R cohorts
Measured: from the 1st August 2020 to 30th September 2024
Discontinuation of ongoing RAASi and/or SGLT-2i treatment among treated patients (proportion of patients, time to discontinuation) in the two cohorts of the study, pre-P&R and post-P&R cohorts.
Measured: from the 1st August 2020 to 30th September 2024
Secondary outcomes (1)
To describe the current clinical landscape among incident renal disease/incident CKD patients and in new initiators of kidney protective treatment- patients during the follow-up period
Measured: from the 1st August 2020 to 30th September 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start4 Dec 2024
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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
- 91,628 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614712
- Sponsor's protocol ID
- D169AR00032
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2024
- Last updated
- 6 Oct 2026
- Results posted
- 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Observational, Retrospective, Secondary Data Study Describing Management and Treatment in Routine Clinical Practice Among Patients With Chronic Kidney Disease. Local Adaptation for Spain. Part 1
- ClinicalTrials.gov ID
- NCT06614712
- Acronym / sponsor ID
- D169AR00032
- Conditions
- Renal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91,628 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 26 Sep 2024 (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.
OPTIMISE-CKD is a retrospective, observational study, using secondary data. The incidence of renal disease, including CKD, using eGFR or UACR laboratory measurements and diagnostic codes will be assessed in the study population. The study will also assess the incidence of selected cardiovascular and renal events and the current use of kidney-protective treatments
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Pre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024)Pre-pricing \& reimbursement, incident renal disease cohort (study observation period 2020- 2024) |
| Cohort 2 | – | Other: Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024)Post-pricing \& reimbursement, incident renal disease cohort (study observation period 2023-2024) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The overall study population will consist of adult patients, aged ≥18 years as of study index date, with their renal function measured
Key inclusion criteria (5 listed)
- Age ≥18 years as of study index date
- With renal function measured as either of the following:
- registered with Chronic Kidney Disease (CKD) diagnosis in the medical history (without biochemical confirmation)
Key exclusion criteria (1 listed)
- History of stage 5 CKD, dialysis, organ transplant, type 1 diabetes, or gestational diabetes on or before the start date of the observation period
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 |
|---|---|---|
| Pre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024)Incident renal disease patients in this cohort are defined as those that newly met the renal function measurement definition stated above, with first-ever registered laboratory UACR and/or eGFR measurements or CKD diagnosis on or after the start date of this cohort study period, the 1st August 2020 and until the 1 st February 2023 (DAPA_CKD P\&R date in Spain). The first of the dates fulfilling any of the criteria defined above for the renal function measurement or CKD diagnosis, is defined as the patient index date-1 of this study cohort. At the index date-1, the renal disease will be staged based on eGFR (and/or UACR measurements in addition, if available) as specified in the KDIGO guidelines. Patients will be followed up from the index date-1 until the end of continuous enrolment, last date of available data or date of death, until the end of the overall observation period. | Other | Cohort 1 |
| Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024)We define the post-P\&R cohort including all incident renal disease patients observed in the dapagliflozin-CKD post-pricing and reimbursement period. Patients in this cohort newly met the renal function measurement definition stated above, with first-ever registered laboratory UACR and/or eGFR measurements or CKD diagnosis on or after the 1 st February 2023 (DAPA_CKD P\&R date in Spain) and until the end of the study observation period. The first of the dates fulfilling any of the criteria defined above for the renal function measurement or CKD diagnosis, is defined as the patient index date-2 of this study cohort. At the index date-2, the renal disease will be staged based on eGFR (and/or UACR measurements in addition, if available) as specified in the KDIGO guidelines. Patients will be followed up from the index date-2 until the end of continuous enrolment, last date of available data or date of death, until the end of the overall study period | Other | Cohort 2 |
Primary outcome
Baseline demographics and clinical characteristics of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Time frame: from the 1st August 2020 to 30th September 2024
Baseline laboratory measures (number of measures per year and their values) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Time frame: from the 1st August 2020 to 30th September 2024
Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Time frame: Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Initiation of kidney-protective treatment (RAASi or SGLT2i or both) among treatment naïve patients in the pre-P&R cohort and post- P&R
Time frame: from the 1st August 2020 to 30th September 2024
Discontinuation of newly initiated RAASi or SGLT-2i treatment in the two cohorts of the study, pre-P&R and post-P&R cohorts
Time frame: from the 1st August 2020 to 30th September 2024
Discontinuation of ongoing RAASi and/or SGLT-2i treatment among treated patients (proportion of patients, time to discontinuation) in the two cohorts of the study, pre-P&R and post-P&R cohorts.
Time frame: from the 1st August 2020 to 30th September 2024
1 secondary outcome
To describe the current clinical landscape among incident renal disease/incident CKD patients and in new initiators of kidney protective treatment- patients during the follow-up period
Time frame: from the 1st August 2020 to 30th September 2024
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 6 Oct 2026.
- 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 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 Renal 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 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 6 Oct 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 of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates. (time frame: from the 1st August 2020 to 30th September 2024). The study lists 6 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 6 Oct 2026.