Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:14 PM
Study NCT ID:
NCT07450820
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14308}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline demographics and clinical characteristics (comorbidities) of the study cohorts', 'timeFrame': 'From 1-Aug-2021 to 31-Dec-2025', 'description': 'Age (years old) Gender (female, N(%)) Comorbidities (N(%) Cardiovascular comorbidity (ICD code) Type 2 diabetes (ICD code) Hypertension (ICD code)'}, {'measure': 'Baseline laboratory measures (number of measures per year and their values)', 'timeFrame': 'From 1-Aug-2021 to 31-Dec-2025'}, {'measure': '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).', 'timeFrame': 'From 1-Aug-2021 to 31-Dec-2025'}, {'measure': 'Compare selected outcomes', 'timeFrame': 'From 1-Aug-2021 to 31-Dec-2025', 'description': 'eGFR decline with time, (difference from baseline value)'}, {'measure': 'Compare selected health-care resource utilization and cost', 'timeFrame': 'From 1-Aug-2021 to 31-Dec-2025', 'description': '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'}]}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': '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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The overall study population will consist of adult (aged \\> 18 years at index date) patients with CKD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Age ≥18 years.\n* 12 months continuous enrolment in the data base prior to index\n* 12 months continuous enrolment in the data base after index date.\n\nExclusion Criteria:\n\n* T1DM on or before index date.\n* Diagnosis of gestational diabetes mellitus on or before index date'}, 'identificationModule': {'nctId': 'NCT07450820', 'briefTitle': 'OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'D169AR00037'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort of patients treated with Dapagliflozin 10 mg', 'description': '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.'}, {'label': 'Comparator cohort without specific treatment for CKD other than RASi', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28002', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'AstraZeneca Clinical Study Information Center', 'role': 'CONTACT', 'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}