A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE)
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| ClinicalTrials.gov Identifier: NCT05901831 |
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Recruitment Status :
Recruiting
First Posted : June 13, 2023
Last Update Posted : April 12, 2024
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Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes.
In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes.
The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is approved for doctors to prescribe to people with CKD and type 2 diabetes.
In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured.
Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with:
- medical problems (also called treatment-emergent adverse events (TEAEs))
- serious TEAEs. An TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important
- higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines.
The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, they will visit the study site at least 6 times.
The study team will:
- collect blood and urine samples
- check the participants' vital signs such as blood pressure and heart rate
- do a physical examination including height and weight
- check the participants' heart health by using an electrocardiogram (ECG)
- do pregnancy tests in women of childbearing potential
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Kidney Disease Type 1 Diabetes Mellitus | Drug: Finerenone Other: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 220 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Parallel-group, Randomized, Prospective, Interventional, Double-blind, Multicenter Global Phase 3 Study to Investigate the Efficacy and Safety of Finerenone Versus Placebo, in Addition to Standard of Care, in Participants With Chronic Kidney Disease and Type 1 Diabetes |
| Actual Study Start Date : | February 26, 2024 |
| Estimated Primary Completion Date : | September 1, 2025 |
| Estimated Study Completion Date : | October 2, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Finerenone arm
Participants with eGFR ≥25 to <60 mL/min/1.73 m^2 at Screening visit will take Finerenone Dose A. Participants with eGFR ≥60 mL/min/1.73 m^2 at Screening visit will take Dose B. Up-titration and down-titration of study intervention will be based on local potassium and kidney function (eGFR) values. Treatment duration is 6 months.
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Drug: Finerenone
Dose A, Dose B, oral |
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Placebo Comparator: Placebo arm
Participants will take Finerenone matching placebo for 6 months.
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Other: Placebo
Oral |
- Change in Urinary albumin-to-creatinine ratio (UACR) [ Time Frame: From baseline up to 6 months ]UACR will be assessed by the Central laboratory.
- Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs) [ Time Frame: From baseline up to 7 months ]
- Number of participants with Hyperkalaemia [ Time Frame: From baseline up to 7 months ]Hyperkalemia will be an adverse events of special interest (AESI).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant must be ≥18 years of age (or the legal age of consent according to local legislation) at the time of signing the informed consent.
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Participants with Type 1 diabetes (T1D), i.e. T1D continuously treated with insulin, started within one year from diagnosis.
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If the onset was after age 35, documentation of the presence of one or more of the following:
- Circulating T1D-associated autoantibodies
- Hospitalization for diabetic ketoacidosis
- Plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose >100 mg/dl).
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HbA1c at Screening <10% (central assessment).
- Note: One reassessment is allowed for HbA1c during the Screening period in case the first measurement is missing/unreadable/invalid.
- K+ ≤ 4.8 mmol/L at Screening (local assessment)
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Participants with a clinical diagnosis of CKD and fulfilling both the criteria (central assessment):
- eGFR ≥25 and <90 mL/min/1.73 m^2 using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 2009 formula at the Screening visit
- UACR ≥200 mg/g (22.6 mg/mmol) to <5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements)
- Participants on a stable (preferably without any change in the dosage for at least 4 weeks prior to the Screening visit) ACEI (Angiotensin-converting enzyme inhibitor) or ARB (Angiotensin receptor blocker) treatment.
Exclusion Criteria:
- Participant with T2D (Type 2 diabetes).
- Participant with mean BP (Blood pressure) higher than 160/100 mmHg or mean systolic BP lower than 90 mmHg at the Screening visit
- Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs).
- Participants with current or previous (within 8 weeks prior to the Screening visit) treatment with a SGLT-2/-1 (Sodium-Glucose co-transporter-2/-1) inhibitor or GLP1 (Glucagon-like peptide-1) receptor agonist.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05901831
| Contact: Bayer Clinical Trials Contact | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
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| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT05901831 |
| Other Study ID Numbers: |
22267 2022-503024-27-00 ( Registry Identifier: CTIS (EU) ) |
| First Posted: | June 13, 2023 Key Record Dates |
| Last Update Posted: | April 12, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Kidney Diseases Renal Insufficiency, Chronic Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Autoimmune Diseases Immune System Diseases Renal Insufficiency Chronic Disease Disease Attributes Pathologic Processes |