Chronic Kidney DiseaseFLAMINGONCT05640180
An Observational Study Called FLAMINgO to Learn More About the Treatment Combination of Finerenone and SGLT2 Inhibitors in People With Long-term Kidney Disease (Chronic Kidney Disease) Together With Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study Results
An observational study of Chronic Kidney Disease and Type 2 Diabetes, run by Bayer at 1 site in United States.
Trial summary
This is an observational study, in which data from the past of people with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study were treated in the past with a type of drug called SGLT2 inhibitor alone or with SGLT2 inhibitors in combination with finerenone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Type 2 Diabetes
- What is being tested?
- Finerenone (Kerendia, BAY94-8862) and Sodium-glucose cotransporter-2 inhibitors (SGLT2i)
- How many people
- 17,847 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2022to 20 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The randomized clinical trials (RCT) source population is comprised from participants who were enrolled in the FIDELIO-DKD and FIGARO-DKD trials, pooled for the FIDELITY analyses. The source population for the real world (RW) cohort are patients in the Optum® Electronic health record (EHR) database, which includes longitudinal patient-level medical record data for ~97 million patients across the United States dating back to January 1st, 2007.
Who may be able to join
- FIDELIO-DKD patients: Participants with a clinical diagnosis of DKD based on either of the following criteria at the Run-in and Screening Visit: Persistent high albuminuria or Persistent very high albuminuria.
- FIGARO-DKD patients: Participants with a clinical diagnosis of DKD based on either of the following criteria at the Run-in and Screening Visit: Persistent high albuminuria or Persistent very high albuminuria.
- Men or women aged 18 years and older
- Women of childbearing potential can only be included in the study if a pregnancy test is negative at the Screening Visit and if they agree to use adequate contraception.
- Diagnosed with type 2 diabetes.
- Prior treatment with Angiotensin-converting-enzyme inhibitors (ACEIs) and Angiotensin receptor blockers (ARBs) as follows:
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- For at least 4 weeks prior to the Run-in Visit, subjects should be treated with either an ACEI or ARB, or both
- Starting with the Run-in Visit, subjects should be treated with only an ACEI or ARB
- For at least 4 weeks prior to the Screening Visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an ACEI or an ARB (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment.
- Serum potassium ≤4.8 mmol/L at both the Run-in and the Screening Visit.
- SGLT2 inhibitor use at baseline: Canagliflozin, Dapagliflozin, Empagliflozin, Ertugliflozin, Ipragliflozin, Luseogliflozin, Tofogliflozin.
Who cannot join
- Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis.
- Urine Albumin-Creatinine Ratio (UACR) >5000 mg/g (>565 mg/mmol) at the Run-in Visit or Screening Visit.
- Hemoglobin A1C (HbA1c) > 12% (> 108 mmol/mol) at the Run-in Visit or Screening Visit.
- Uncontrolled arterial hypertension with mean sitting systolic blood pressure (SBP) ≥170 mmHg or mean sitting diastolic blood pressure (DBP) ≥110 mmHg at the Run-in Visit or mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at the Screening Visit.
- Mean SBP < 90 mmHg at the Run-in Visit or at the Screening Visit.
- Subjects with a clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II - IV) at the Run-in Visit (class 1A recommendation for MRAs).
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- Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the Screening Visit.
- Dialysis for acute renal failure within 12 weeks prior to the Run-in Visit.
- Renal allograft in place or a scheduled kidney transplant within the next 12 months from the Run-in Visit.
- Addison's disease.
- Hepatic insufficiency classified as Child-Pugh C.
- Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic which cannot be discontinued at least 4 weeks prior to the Screening Visit.
- Concomitant therapy with both ACEI and ARBs which cannot be discontinued for the purpose of the study.
- Concomitant therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers (to be stopped at least 7 days before randomization).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Finerenone on Top of SGLT2is: A coMparatIve Hybrid Study Based oN RCT/RWE Data Of Patients With Chronic Kidney Disease Associated With Type 2 Diabetes
This is an observational study, in which data from the past of people with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study were treated in the past with a type of drug called SGLT2 inhibitor alone or with SGLT2 inhibitors in combination with finerenone.
In observational studies, only observations are made without specified advice or interventions.
Read more
CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. Chronic kidney disease often occurs together with / as a consequence of type 2 diabetes.
SGLT2 inhibitors lower blood sugar levels by increasing sugar removal from the blood into the urine. SGLT2 inhibitors are the standard of care (SOC) treatment for CKD and T2D. SOC is the treatment that medical experts consider most appropriate for a disease. The drug finerenone works by blocking certain proteins, called mineralocorticoid receptors.
By doing this, finerenone reduces damage to kidneys, heart and blood vessels. It is available and approved for doctors to prescribe to people with CKD together with T2D.
Results from two earlier clinical studies called FIDELIO-DKD and FIGARO-DKD in participants with CKD together with T2D are available. These results suggest that the treatment combination of finerenone and SGLT2 inhibitors may work better than taking SGLT2 inhibitors alone. The treatment combination may further slow down a worsening of the participants'
- kidney disease
- heart and blood circulation health.
Due to a limited number of participants treated with SGLT2 inhibitors alone however, the data from the two earlier studies does not allow to draw conclusions.
The main objective of this study is to combine additional real world data from SGLT2 inhibitor users with the study data from the earlier studies to get clearer results. Before combining the data however, statistical tests need to prove that this is allowed. If this is the case, the new combined "control" data can be compared with the data from the combination treatment group from the earlier studies. This will allow the researchers to get more proof and draw conclusions of how well the treatment combination works compared to SGLT2 inhibitors alone.
The real world data will come from a database called Optum. It will cover the period from January 2013 to September 2021. Only data from people who are similar to the participants of the control group of the earlier studies and meet certain criteria will be selected.
Only data from the past is collected and studied. There are no required visits or tests in this study.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Being tested
- Finerenone (Kerendia, BAY94-8862), Sodium-glucose cotransporter-2 inhibitors (SGLT2i)
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (Kerendia, BAY94-8862)Drug
Retrospective cohort analysis using randomized clinical trials data.
Sodium-glucose cotransporter-2 inhibitors (SGLT2i)Drug
Retrospective cohort analysis using United States Optum Electronic Health Records data.
| Study group | Role | What they receive |
|---|---|---|
| External control arm (ECA) | ECA built from patients from Optum® Electronic Health Records (EHR) real world data (RWD) that closely match Sodium/glucose cotransporter-2 inhibitors (SGLT2i) subgroups from the randomized clinical trials (RCTs). Receives: Drug: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) | |
| Internal control arm (ICA) | ICA built from participants from two RCTs called FIDELIO-DKD and FIGARO-DKD pooled for the FIDELITY analyses. FIDELIO-DKD/FIGARO-DKD placebo controls treated with SGLT2is at baseline. Receives: Drug: Finerenone (Kerendia, BAY94-8862); Drug: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death
Measured: From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months
Time to first occurrence of the composite endpoint of Cardiovascular (CV) death or non-fatal CV event (i.e. myocardial infarction, stroke, or hospitalization for heart failure)
Measured: From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months
Secondary outcomes (4)
Time to all-cause hospitalization
Measured: From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with a maximum follow-up time of 48 months
Time to all-cause mortality
Measured: From randomization up until death due to any cause, or censoring at the end of the study, with a maximum follow-up time of 48 months
Change in urine albumin-creatinine ratio (UACR) from baseline to Month 4
Measured: From baseline to Month 4
Time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease in eGFR of ≥ 57% from baseline over at least 4 weeks or renal death
Measured: From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start23 Nov 2022
- Primary completion20 Dec 2023
- Study completion20 Dec 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 BayerThe 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
- 17,847 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640180
- Sponsor's protocol ID
- 22304
- Acronym
- FLAMINGO
- Status last verified
- Jan 2024
- First submitted
- 21 Nov 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finerenone on Top of SGLT2is: A coMparatIve Hybrid Study Based oN RCT/RWE Data Of Patients With Chronic Kidney Disease Associated With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05640180
- Acronym / sponsor ID
- FLAMINGO / 22304
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,847 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 7 Dec 2022 (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 an observational study, in which data from the past of people with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study were treated in the past with a type of drug called SGLT2 inhibitor alone or with SGLT2 inhibitors in combination with finerenone.
In observational studies, only observations are made without specified advice or interventions.
CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. Chronic kidney disease often occurs together with / as a consequence of type 2 diabetes.
SGLT2 inhibitors lower blood sugar levels by increasing sugar removal from the blood into the urine. SGLT2 inhibitors are the standard of care (SOC) treatment for CKD and T2D. SOC is the treatment that medical experts consider most appropriate for a disease. The drug finerenone works by blocking certain proteins, called mineralocorticoid receptors.
By doing this, finerenone reduces damage to kidneys, heart and blood vessels. It is available and approved for doctors to prescribe to people with CKD together with T2D.
Results from two earlier clinical studies called FIDELIO-DKD and FIGARO-DKD in participants with CKD together with T2D are available. These results suggest that the treatment combination of finerenone and SGLT2 inhibitors may work better than taking SGLT2 inhibitors alone. The treatment combination may further slow down a worsening of the participants'
- kidney disease
- heart and blood circulation health.
Due to a limited number of participants treated with SGLT2 inhibitors alone however, the data from the two earlier studies does not allow to draw conclusions.
The main objective of this study is to combine additional real world data from SGLT2 inhibitor users with the study data from the earlier studies to get clearer results. Before combining the data however, statistical tests need to prove that this is allowed. If this is the case, the new combined "control" data can be compared with the data from the combination treatment group from the earlier studies. This will allow the researchers to get more proof and draw conclusions of how well the treatment combination works compared to SGLT2 inhibitors alone.
The real world data will come from a database called Optum. It will cover the period from January 2013 to September 2021. Only data from people who are similar to the participants of the control group of the earlier studies and meet certain criteria will be selected.
Only data from the past is collected and studied. There are no required visits or tests in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External control arm (ECA) | – | Drug: Sodium-glucose cotransporter-2 inhibitors (SGLT2i)ECA built from patients from Optum® Electronic Health Records (EHR) real world data (RWD) that closely match Sodium/glucose cotransporter-2 inhibitors (SGLT2i) subgroups from the randomized clinical trials (RCTs). |
| Internal control arm (ICA) | – | Drug: Finerenone (Kerendia, BAY94-8862), Drug: Sodium-glucose cotransporter-2 inhibitors (SGLT2i)ICA built from participants from two RCTs called FIDELIO-DKD and FIGARO-DKD pooled for the FIDELITY analyses. FIDELIO-DKD/FIGARO-DKD placebo controls treated with SGLT2is at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The randomized clinical trials (RCT) source population is comprised from participants who were enrolled in the FIDELIO-DKD and FIGARO-DKD trials, pooled for the FIDELITY analyses. The source population for the real world (RW) cohort are patients in the Optum® Electronic health record (EHR) database, which includes longitudinal patient-level medical record data for ~97 million patients across the United States dating back to January 1st, 2007.
Key inclusion criteria (11 listed)
- FIDELIO-DKD patients: Participants with a clinical diagnosis of DKD based on either of the following criteria at the Run-in and Screening Visit: Persistent high albuminuria or Persistent very high albuminuria.
- FIGARO-DKD patients: Participants with a clinical diagnosis of DKD based on either of the following criteria at the Run-in and Screening Visit: Persistent high albuminuria or Persistent very high albuminuria.
- Men or women aged 18 years and older
- Women of childbearing potential can only be included in the study if a pregnancy test is negative at the Screening Visit and if they agree to use adequate contraception.
- Diagnosed with type 2 diabetes.
Key exclusion criteria (14 listed)
- Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis.
- Urine Albumin-Creatinine Ratio (UACR) >5000 mg/g (>565 mg/mmol) at the Run-in Visit or Screening Visit.
- Hemoglobin A1C (HbA1c) > 12% (> 108 mmol/mol) at the Run-in Visit or Screening Visit.
- Uncontrolled arterial hypertension with mean sitting systolic blood pressure (SBP) ≥170 mmHg or mean sitting diastolic blood pressure (DBP) ≥110 mmHg at the Run-in Visit or mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at the Screening Visit.
- Mean SBP < 90 mmHg at the Run-in Visit or at the Screening Visit.
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 |
|---|---|---|
| Finerenone (Kerendia, BAY94-8862)Retrospective cohort analysis using randomized clinical trials data. | Drug | Internal control arm (ICA) |
| Sodium-glucose cotransporter-2 inhibitors (SGLT2i)Retrospective cohort analysis using United States Optum Electronic Health Records data. | Drug | External control arm (ECA), Internal control arm (ICA) |
Primary outcome
Time to the first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death
Time frame: From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months
Time to first occurrence of the composite endpoint of Cardiovascular (CV) death or non-fatal CV event (i.e. myocardial infarction, stroke, or hospitalization for heart failure)
Time frame: From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months
4 secondary outcomes
Time to all-cause hospitalization
Time frame: From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with a maximum follow-up time of 48 months
Time to all-cause mortality
Time frame: From randomization up until death due to any cause, or censoring at the end of the study, with a maximum follow-up time of 48 months
Change in urine albumin-creatinine ratio (UACR) from baseline to Month 4
Time frame: From baseline to Month 4
Time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease in eGFR of ≥ 57% from baseline over at least 4 weeks or renal death
Time frame: From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months
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 8 Jan 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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 and Type 2 Diabetes, run by Bayer at 1 site in United States.
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 11 inclusion and 14 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 8 Jan 2024. 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 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?
Time to the first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death (time frame: From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months). The study lists 2 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 8 Jan 2024.