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

Study analyzes how well Dapagliflozin works for kidney disease patients in Spain.

NCT: NCT07450820 · Status: RECRUITING · Phase: N/A · Sponsor: AstraZeneca · Started: 2026-02-18 · Est. Completion: 2027-02-09

Plain English Summary

OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD is a Not Applicable clinical trial sponsored by AstraZeneca studying Chronic Kidney Disease. This study looks at how effective the drug Dapagliflozin is for people with chronic kidney disease (CKD) in real-world medical settings in Spain. It is for adults diagnosed with chronic kidney disease. Participation involves reviewing existing patient health records; no new treatments or procedures are given. Alternatives include other prescribed CKD treatments or lifestyle changes recommended by a doctor. The trial aims to enroll 14308 participants.

Official 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 observation period of 39 months (August 2020-November 2024) in two cohorts (preand post-reimbursement of Dapagliflozin for CKD)

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of chronic kidney disease. Patients must have specific kidney function test results (eGFR and/or UACR) and a history of at least 12 months in the database before and after a specific study date. Individuals with Type 1 diabetes or gestational diabetes are not eligible. This trial is studying Chronic Kidney Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes will show how Dapagliflozin affects patient characteristics, lab results, and the use of other medications, helping doctors understand its impact on kidney disease management. The specific primary outcome measures are: Baseline demographics and clinical characteristics (comorbidities) of the study cohorts (From 1-Aug-2021 to 31-Dec-2025); Baseline laboratory measures (number of measures per year and their values) (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). (From 1-Aug-2021 to 31-Dec-2025); Compare selected outcomes (From 1-Aug-2021 to 31-Dec-2025); Compare selected health-care resource utilization and cost (From 1-Aug-2021 to 31-Dec-2025). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it will provide insights into how well Dapagliflozin works in everyday clinical practice for kidney disease patients, helping to fill a gap in understanding its real-wo This research targets Chronic Kidney Disease, where improved treatment options are needed.

Investor Insight

This observational study on Dapagliflozin in CKD could signal strong market confidence and potential for expanded use, given the significant prevalence of kidney disease and the drug's established rol The large enrollment target of 14308 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your medical records are being used for this study and what it means for your privacy. Understand that this study uses past data, so your day-to-day routine will not change as a result of your participation. Inquire about other treatment options available for your kidney disease. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Primary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* T1DM on or before index date.
* Diagnosis of gestational diabetes mellitus on or before index date

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07450820?

NCT07450820 is a Not Applicable OBSERVATIONAL study titled "OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD." It is currently recruiting and is sponsored by AstraZeneca. The trial targets enrollment of 14308 participants.

What conditions does NCT07450820 study?

This trial investigates treatments for Chronic Kidney Disease. The primary condition under study is Chronic Kidney Disease.

What does Not Applicable mean for NCT07450820?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT07450820?

This trial is currently "Recruiting." It started on 2026-02-18. The estimated completion date is 2027-02-09.

Who is sponsoring NCT07450820?

NCT07450820 is sponsored by AstraZeneca. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07450820?

The trial aims to enroll 14308 participants. The trial is currently recruiting and accepting new participants.

How is NCT07450820 designed?

This is a observational study.

What are the primary outcomes being measured in NCT07450820?

The primary outcome measures are: Baseline demographics and clinical characteristics (comorbidities) of the study cohorts (From 1-Aug-2021 to 31-Dec-2025); Baseline laboratory measures (number of measures per year and their values) (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). (From 1-Aug-2021 to 31-Dec-2025); Compare selected outcomes (From 1-Aug-2021 to 31-Dec-2025); Compare selected health-care resource utilization and cost (From 1-Aug-2021 to 31-Dec-2025). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07450820 being conducted?

This trial is being conducted at 1 site, including Madrid (Spain).

Where can I find official information about NCT07450820?

The official record for NCT07450820 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07450820. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07450820 testing in simple terms?

This study looks at how effective the drug Dapagliflozin is for people with chronic kidney disease (CKD) in real-world medical settings in Spain. It is for adults diagnosed with chronic kidney disease.

Why is this trial significant?

This trial is important because it will provide insights into how well Dapagliflozin works in everyday clinical practice for kidney disease patients, helping to fill a gap in understanding its real-wo

What are the potential risks of participating in NCT07450820?

As this is an observational study using existing data, direct risks to patients are minimal. Potential risks are those already associated with Dapagliflozin treatment, such as urinary tract infections or dehydration, which your doctor monitors. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07450820?

Ask your doctor if your medical records are being used for this study and what it means for your privacy. Understand that this study uses past data, so your day-to-day routine will not change as a result of your participation. Inquire about other treatment options available for your kidney disease. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07450820 signal from an investment perspective?

This observational study on Dapagliflozin in CKD could signal strong market confidence and potential for expanded use, given the significant prevalence of kidney disease and the drug's established rol This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves reviewing existing patient health records; no new treatments or procedures are given. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.