Chronic Kidney DiseasePhase 2FIGARO-BMNCT05013008
An add-on Study to the FIGARO-DKD Study Called FIGARO-BM to Learn About the Link Between Biomarkers (Substances in the Blood Used as Indicators of Biological Processes, Disease Processes or Responses to Medication) and Finerenone in FIGARO-DKD Participants
A Phase 2 study testing Finerenone (Kerendia, BAY94-8862) in people with Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 115 sites in 21 countries.
Trial summary
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a long-term, progressive decrease in the kidneys' ability to work properly. When CKD happens in people with type 2 diabetes mellitus, a condition characterized by high blood sugar levels, CKD is also referred to as diabetic… 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 Mellitus
- What is being tested?
- Finerenone (Kerendia, BAY94-8862)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 951 participants
- Where
- 115 sitesin 21 countries
- Study dates
- 18 Aug 2021to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- This study will only include participants who were enrolled in the FIGARO-DKD study (NCT02545049) and had received up to 20 mg finerenone or placebo for ≥24 months.
- For each participant, pharmacokinetic (PK) plasma samples from Visit 3 and at least 2 other Visits (Visit 5, Visit 8, Visit 11) must be available on storage from the main study FIGARO-DKD.
Who cannot join
- Participants which did not show overall compliance of 80 to 120% with study intervention in FIGARO-DKD.
- Participants which were not part of the full analysis set (FAS) of FIGARO-DKD.
- Participants with known fatal outcome.
- Participants with baseline estimated glomerular filtration rate (eGFR) ≤25 mL/min/1.73m^2.
- Participants with low baseline risk (normal albuminuria and eGFR≥60 mL/min/1.73m^2).
- Sponsor request (after discussion with the investigator), for reasons such as a significant protocol deviation.
Trial locations and contacts
115 sites in 21 countries.
115 sites in 21 countries
Japan22 sites
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-8502
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, 251-0041
Fukuoka University Hospital
Fukuoka, 814-0180
Higashihiroshima Medical Center
Higashihiroshima, Hiroshima, 739-0041
Kohnodai Hospital, NC for Global Health and Medicine
Ichikawa, Chiba, 272-8516
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533
Fukuoka Tokushukai Hospital
Kasuga, Fukuoka, 816-0864
Sugiura Clinic
Kawaguchi, Saitama, 332-0012
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
Steel Memorial Yawata Hospital
Kitakyushu, Fukuoka, 805-8508
Komatsu Municipal Hospital
Komatsu, Ishikawa-ken, 923-8560
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861-8520
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, 791-8026
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, 852-8511
Nakakinen Clinic
Naka, Ibaraki, 311-0113
Jiyugaoka YAMADA Clinic
Obihiro, Hokkaido, 080-0848
Kyosokai AMC NISHI-UMEDA Clinic
Osaka, 530-0001
Kitano Hospital
Osaka, 530-8480
Association of healthcare corporation, Oyama East Clinic
Oyama, Tochigi, 323-0022
Shirakawa Kosei General Hospital
Shirakawa, Fukushima, 961-0005
Osaka Saiseikai Senri Hospital
Suita, Osaka, 565-0862
Noritake Clinic
Ushiku, Ibaraki, 300-1207
Russia14 sites
First City Clinical Hospital n.a. E.E. Volosevich
Arkhangelsk, 163001
Izhevsk City Clinical Hospital #9
Izhevsk, 426063
Sci-Res. Institute of Complex Cardiovascular Disorders
Kemerovo, 650002
Kemerovo Regional Clinical Hospital
Kemerovo, 650066
Center of cardiology and neurology
Kirov, 610014
Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky
Krasnodar, 350086
Moscow State University n.a. M.V. Lomonosov
Moscow, 119192
Moscow State Univ. of Med. & Stomatology n.a. A.I. Evdokimov
Moscow, 123182
PHI "Central Clinical Hospital "RZD-Medicine"
Moscow, 125315
City Clinical Hospital #13 Nizhny Novgorod
Nizhny Novgorod, 603018
Saratov City Clinical Hospital #9
Saratov, 410030
Voronezh Regional Clinical Consultancy-Diagnostic Center
Voronezh, 394018
City Outpatient Clinic #4
Voronezh, 394077
Clinical Hospital for Emergency Care n.a. N.V.Solovyov
Yaroslavl, 150003
United States13 sites
Randolph Medical Associates
Asheboro, North Carolina, 27203
Joslin Diabetes Center
Boston, Massachusetts, 02215
Florida Kidney Physicians - Fort Lauderdale
Fort Lauderdale, Florida, 33308
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Crescent City Clinical Research Center, LLC
Metairie, Louisiana, 70006
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016
Valley Clinical Trials, Inc. - Northridge
Northridge, California, 91325
Saviers Medical Group
Port Hueneme, California, 93041
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212-4740
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Denmark9 sites
Aarhus Universitetshospital, Skejby
Aarhus N, 8200
Sydvestjysk Sygehus Esbjerg, Endocrinology dept.
Esbjerg, 6700
Capital Region | Gentofte Hospital - Cardiology Research
Hellerup, 2900
Herlev Hospital - Endocrinology dept.
Herlev, 2730
Steno Diabetes Center Copenhagen
Herlev, 2730
Holbæk Sygehus
Holbæk, 4300
Holstebro Hospital, Endocrinology dept.
Holstebro, DK-7500
Bispebjerg Hospital
København NV, 2400
Viborg Sygehus
Viborg, 8800
Israel7 sites
Barzilai Medical Center | Nephrology & Hypertension Dept.
Ashkelon, 7830604
Edith Wolfson Medical Center
Holon, 5822012
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, 9112001
Meir Medical Center
Kfar Saba, 4428164
The Nazareth Trust Hospital EMMS
Nazareth, 16100
Clalit Health Services, Midgal Hamea
Tel Aviv, 6203854
DMC - Diabetes Medical Center
Tel Aviv, 6937947
South Korea7 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggido, 14068
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
Korea University Anam Hospital
Seoul, 02841
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Kangbuk Samsung Hospital
Seoul, 110-746
Severance Hospital, Yonsei University Health System
Seoul, 3722
Yonsei University Wonju Christian Hospital
Wŏnju, Gang''weondo, 26426
Taiwan6 sites
Changhua Christian Hospital
Changhua, 50006
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, 833
Far Eastern Memorial Hospital | Nephrology Department
New Taipei City, 220
Taichung Veterans General Hospital
Taichung, 40705
Taipei Medical University Hospital
Taipei, 110
Taipei Veterans General Hospital
Taipei, 11217
Spain5 sites
Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
A Coruña, A Coruña, 15006
Hospital del Mar | Nephrology Department
Barcelona, 08003
Hospital SAS de Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
Lugar Da Pega, A Coruña, 15405
Hospital Universitario 12 de Octubre
Madrid, 28041
Canada4 sites
Hopital Charles LeMoyne
Greenfield Park, Quebec, J4V 2H1
Manna Research (Mirabel)
Mirabel, Quebec, J7J 2K8
Fraser Clinical Trials, Inc.
New Westminster, British Columbia, V3L 3W4
Clinique des Maladies Lipidques de Quebec
Québec, G1V 4W1
Italy4 sites
Istituto Ricerche Farmacologiche Mario Negri IRCCS
Bergamo, Lombardy, 24020
ASST Papa Giovanni XXIII
Bergamo, Lombardy, 24127
A.O.U. di Bologna Policlinico S.Orsola Malpighi
Bologna, Emilia-Romagna, 40138
ASST Santi Paolo e Carlo
Milan, Lombardy, 20142
Austria3 sites
Medizinische Universität Graz
Graz, Styria, 8036
Klinik Landstraße - Krankenhaus Rudolfstiftung
Vienna, 1030
Zentrum f. klinische Studien Dr. Hanusch GmbH
Vienna, 1060
Bulgaria3 sites
Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department
Gorna Oryahovitsa, 5100
DCC 2 - Plovdiv EOOD
Plovdiv, 4002
MHAT Sveti Pantaleymon - Yambol
Yambol, 8600
Finland3 sites
Terveystalo Oulu
Oulu, 90100
Lääkärikeskus Minerva
Rauma, 26100
Turun yliopistollinen keskussairaala
Turku, 20520
Hong Kong3 sites
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital Hong Kong
Shatin
Tung Wah Hospital
Sheung Wan
Sweden3 sites
PTC-Primary care Trial Center
Gothenburg, 413 46
Avdelningen för kliniska prövningar AKP
Örebro, 703 62
ClinSmart
Uppsala, 752 37
Australia2 sites
Melbourne Renal Research Group
Reservoir, Victoria, 3073
Illawarra Diabetes Service
Wollongong, New South Wales, 2500
Singapore2 sites
Singapore General Hospital
Singapore, 169608
National Heart Centre Singapore
Singapore, 169609
Netherlands1 site
Albert Schweitzer Ziekenhuis, locatie Zwijndrecht
Zwijndrecht, 3331 LZ
About this study
Official title: A Non-blinded Retrospective Biomarker add-on Study to FIGARO-DKD for Bioprofiling the Pharmacodynamic Response to Finerenone in FIGARO-DKD Subjects
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a long-term, progressive decrease in the kidneys' ability to work properly. When CKD happens in people with type 2 diabetes mellitus, a condition characterized by high blood sugar levels, CKD is also referred to as diabetic kidney disease (DKD).
FIGARO-BM is an add-on study in which blood draws that were collected in the FIGARO-DKD study are further analyzed. No additional blood draws (also referred to as biological samples) or data will be obtained from the participants, nor will any additional or new study intervention be introduced. No visit or patient contact other than for obtaining the agreement by the patients (also called informed consent) will be required.
Read more
Inflammation and scarring are both seen as responsible for worsening of chronic kidney disease. There is much information from animal studies that the study treatment finerenone (BAY94-8862) works against inflammation and against scarring (also called fibrosis) in organs such as the kidney.
In this exploratory study researchers want to learn more about the study treatment finerenone (BAY94-8862). To find this out, this study will examine substances called biomarkers in blood draws from participants in the FIGARO-DKD study. Biomarkers are used as indicators of biological processes, disease processes or responses to medication. The biomarkers that will be examined stand for inflammation, organ scarring (also called fibrosis), blood vessel function and congestion.
The main question of this study is whether there are differences between these biomarkers in the group of participants who received finerenone and the group of participants who received a placebo in the FIGARO-DKD study. A placebo looks like a treatment but does not have any medicine in it. To answer this question, the researchers will compare the levels of these biomarkers between the two groups at different time points after starting the study treatment. Blood samples for this study will be obtained from FIGARO-DKD study sites with a high number of participants who had been treated with finerenone or placebo for at least 24 months. This information will be combined with other information from biomarker examinations already available in the FIGARO-DKD study.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Being tested
- Finerenone (Kerendia, BAY94-8862), Placebo
- 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
Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study.
PlaceboDrug
Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. Receives: Drug: Finerenone (Kerendia, BAY94-8862) |
| Placebo | Placebo comparator | Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers
The normalized protein expression (NPX) of biomarker levels were analyzed for the set of 27 pre-defined plasma biomarkers. NPX is a unit on log2-scale that is logarithmically related to protein concentration. Linear NPX (2^NPX) was calcuated for descriptive analyses of the biomarker levels at each visit. Ratios of Visit 11 (36 months of treatment) to Visit 3 (4 months of treatment) were calculated to show the change in the plasma biomarker levels. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. Note, NPX units (Olink concentration units) are always relative units and can only be interpreted in the context of an individual study, i.e. to compare two conditions or timepoints ("change in NPX"). Equal nominal concentration values (same NPX units) for two different biomarkers measured by Olink Explore does not mean that both markers have the same absolute concentration.
Measured: At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start18 Aug 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 951 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013008
- Sponsor's protocol ID
- 21952
- Other IDs
- 2021-003053-37
- Acronym
- FIGARO-BM
- Status last verified
- Sep 2023
- First submitted
- 20 Jul 2021
- Last updated
- 15 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-blinded Retrospective Biomarker add-on Study to FIGARO-DKD for Bioprofiling the Pharmacodynamic Response to Finerenone in FIGARO-DKD Subjects
- ClinicalTrials.gov ID
- NCT05013008
- Acronym / sponsor ID
- FIGARO-BM / 21952
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 951 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Posted 31 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a long-term, progressive decrease in the kidneys' ability to work properly. When CKD happens in people with type 2 diabetes mellitus, a condition characterized by high blood sugar levels, CKD is also referred to as diabetic kidney disease (DKD).
FIGARO-BM is an add-on study in which blood draws that were collected in the FIGARO-DKD study are further analyzed. No additional blood draws (also referred to as biological samples) or data will be obtained from the participants, nor will any additional or new study intervention be introduced. No visit or patient contact other than for obtaining the agreement by the patients (also called informed consent) will be required.
Inflammation and scarring are both seen as responsible for worsening of chronic kidney disease. There is much information from animal studies that the study treatment finerenone (BAY94-8862) works against inflammation and against scarring (also called fibrosis) in organs such as the kidney.
In this exploratory study researchers want to learn more about the study treatment finerenone (BAY94-8862). To find this out, this study will examine substances called biomarkers in blood draws from participants in the FIGARO-DKD study. Biomarkers are used as indicators of biological processes, disease processes or responses to medication. The biomarkers that will be examined stand for inflammation, organ scarring (also called fibrosis), blood vessel function and congestion.
The main question of this study is whether there are differences between these biomarkers in the group of participants who received finerenone and the group of participants who received a placebo in the FIGARO-DKD study. A placebo looks like a treatment but does not have any medicine in it. To answer this question, the researchers will compare the levels of these biomarkers between the two groups at different time points after starting the study treatment. Blood samples for this study will be obtained from FIGARO-DKD study sites with a high number of participants who had been treated with finerenone or placebo for at least 24 months. This information will be combined with other information from biomarker examinations already available in the FIGARO-DKD study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: Finerenone (Kerendia, BAY94-8862)Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- This study will only include participants who were enrolled in the FIGARO-DKD study (NCT02545049) and had received up to 20 mg finerenone or placebo for ≥24 months.
- For each participant, pharmacokinetic (PK) plasma samples from Visit 3 and at least 2 other Visits (Visit 5, Visit 8, Visit 11) must be available on storage from the main study FIGARO-DKD.
Key exclusion criteria (6 listed)
- Participants which did not show overall compliance of 80 to 120% with study intervention in FIGARO-DKD.
- Participants which were not part of the full analysis set (FAS) of FIGARO-DKD.
- Participants with known fatal outcome.
- Participants with baseline estimated glomerular filtration rate (eGFR) ≤25 mL/min/1.73m^2.
- Participants with low baseline risk (normal albuminuria and eGFR≥60 mL/min/1.73m^2).
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)Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study. | Drug | Finerenone |
| PlaceboOral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study. | Drug | Placebo |
Primary outcome
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers
Time frame: At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment
The normalized protein expression (NPX) of biomarker levels were analyzed for the set of 27 pre-defined plasma biomarkers. NPX is a unit on log2-scale that is logarithmically related to protein concentration. Linear NPX (2^NPX) was calcuated for descriptive analyses of the biomarker levels at each visit. Ratios of Visit 11 (36 months of treatment) to Visit 3 (4 months of treatment) were calculated to show the change in the plasma biomarker levels. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. Note, NPX units (Olink concentration units) are always relative units and can only be interpreted in the context of an individual study, i.e. to compare two conditions or timepoints ("change in NPX"). Equal nominal concentration values (same NPX units) for two different biomarkers measured by Olink Explore does not mean that both markers have the same absolute concentration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
- 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.
Related trials for Chronic Kidney Disease
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
RecruitingObservational study
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Gastric Antral Vascular Ectasia, Cirrhosis
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.
115 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finerenone (Kerendia, BAY94-8862) in people with Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 115 sites in 21 countries.
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 2 inclusion and 6 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in Japan, Russia, United States, Denmark, Israel and 16 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers (time frame: At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment). 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 15 Sep 2023.