Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial
PLS Type 1 diabetes is a condition where people have high blood sugar due to insufficient production of a protein called insulin. People with type 1 diabetes can often develop kidney disease. Eventually, their kidneys may stop working, resulting in the need for a procedure called dialysis which remo...
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| creator | Heerspink, Hiddo J.L. Birkenfeld, Andreas L. Cherney, David Z.I. Colhoun, Helen M. Ji, Linong Mathieu, Chantal Groop, Per-Henrik Pratley, Richard E. Rosas, Sylvia E. Rossing, Peter Skyler, Jay S. Tuttle, Katherine R. Lawatscheck, Robert Scott, Charlie Edfors, Robert Scheerer, Markus F. Kolkhof, Peter McGill, Janet B. |
| description | PLS Type 1 diabetes is a condition where people have high blood sugar due to insufficient production of a protein called insulin. People with type 1 diabetes can often develop kidney disease. Eventually, their kidneys may stop working, resulting in the need for a procedure called dialysis which removes waste products from the body. In addition, people with type 1 diabetes and kidney disease are at higher risk of heart disease and tend to have a shorter life expectancy than people with type 1 diabetes without kidney disease. Here, the authors describe the design of a study in people with type 1 diabetes with kidney disease, called FINE-ONE. FINE-ONE is studying whether a drug called finerenone can slow down the progression of kidney disease. The FINE-ONE study will look at whether finerenone will reduce the amount of a protein called albumin in the urine. A high level of albumin in the urine is commonly recognized to be a sign of kidney disease. Reducing the amount of urine albumin with finerenone would show that finerenone can protect the kidneys of people with type 1 diabetes with kidney disease. If the study is successful, finerenone could be the first drug for kidney protection available to patients with type 1 diabetes in 30 years. Finerenone is already approved for the treatment of patients with type 2 diabetes and kidney disease.
[Display omitted]
•Finerenone is indicated for the treatment of chronic kidney disease (CKD) in type 2 diabetes.•The FINE-ONE clinical trial is investigating the effect of finerenone in people with type 1 diabetes and CKD.•The trial is investigating change in albuminuria from baseline over 6 months.•Albuminuria will be used as a bridging biomarker for regulatory approval purposes in type 1 diabetes and CKD.•Finerenone could become a new registered treatment for CKD progression in type 1 diabetes.
Despite guideline-recommended treatments, including renin angiotensin system inhibition, up to 40 % of individuals with type 1 diabetes develop chronic kidney disease (CKD) putting them at risk of kidney failure. Finerenone is approved to reduce the risk of kidney failure in individuals with type 2 diabetes. We postulate that finerenone will demonstrate benefits on kidney outcomes in people with type 1 diabetes.
FINE-ONE (NCT05901831) is a randomised, placebo-controlled, double-blind phase III trial of 7.5 months’ duration in ∼220 adults with type 1 diabetes, urine albumin/creatinine ratio (UACR) of ≥ 200–< 5000 mg/g (≥ 22.6–< 565 m |
| doi_str_mv | 10.1016/j.diabres.2023.110908 |
| format | Article |
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[Display omitted]
•Finerenone is indicated for the treatment of chronic kidney disease (CKD) in type 2 diabetes.•The FINE-ONE clinical trial is investigating the effect of finerenone in people with type 1 diabetes and CKD.•The trial is investigating change in albuminuria from baseline over 6 months.•Albuminuria will be used as a bridging biomarker for regulatory approval purposes in type 1 diabetes and CKD.•Finerenone could become a new registered treatment for CKD progression in type 1 diabetes.
Despite guideline-recommended treatments, including renin angiotensin system inhibition, up to 40 % of individuals with type 1 diabetes develop chronic kidney disease (CKD) putting them at risk of kidney failure. Finerenone is approved to reduce the risk of kidney failure in individuals with type 2 diabetes. We postulate that finerenone will demonstrate benefits on kidney outcomes in people with type 1 diabetes.
FINE-ONE (NCT05901831) is a randomised, placebo-controlled, double-blind phase III trial of 7.5 months’ duration in ∼220 adults with type 1 diabetes, urine albumin/creatinine ratio (UACR) of ≥ 200–< 5000 mg/g (≥ 22.6–< 565 mg/mmol) and eGFR of ≥ 25–< 90 ml/min/1.73 m2.
The primary endpoint is relative change in UACR from baseline over 6 months. UACR is used as a bridging biomarker (BB), since the treatment effect of finerenone on UACR was associated with its efficacy on kidney outcomes in the type 2 diabetes trials. Based on regulatory authority feedback, UACR can be used as a BB for kidney outcomes to support registration of finerenone in type 1 diabetes, provided necessary criteria are met. Secondary outcomes include incidences of treatment-emergent adverse events, treatment-emergent serious adverse events and hyperkalaemia.
FINE-ONE will evaluate the efficacy and safety of finerenone in type 1 diabetes and CKD. Finerenone could become the first registered treatment for CKD associated with type 1 diabetes in almost 30 years.
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[Display omitted]
•Finerenone is indicated for the treatment of chronic kidney disease (CKD) in type 2 diabetes.•The FINE-ONE clinical trial is investigating the effect of finerenone in people with type 1 diabetes and CKD.•The trial is investigating change in albuminuria from baseline over 6 months.•Albuminuria will be used as a bridging biomarker for regulatory approval purposes in type 1 diabetes and CKD.•Finerenone could become a new registered treatment for CKD progression in type 1 diabetes.
Despite guideline-recommended treatments, including renin angiotensin system inhibition, up to 40 % of individuals with type 1 diabetes develop chronic kidney disease (CKD) putting them at risk of kidney failure. Finerenone is approved to reduce the risk of kidney failure in individuals with type 2 diabetes. We postulate that finerenone will demonstrate benefits on kidney outcomes in people with type 1 diabetes.
FINE-ONE (NCT05901831) is a randomised, placebo-controlled, double-blind phase III trial of 7.5 months’ duration in ∼220 adults with type 1 diabetes, urine albumin/creatinine ratio (UACR) of ≥ 200–< 5000 mg/g (≥ 22.6–< 565 mg/mmol) and eGFR of ≥ 25–< 90 ml/min/1.73 m2.
The primary endpoint is relative change in UACR from baseline over 6 months. UACR is used as a bridging biomarker (BB), since the treatment effect of finerenone on UACR was associated with its efficacy on kidney outcomes in the type 2 diabetes trials. Based on regulatory authority feedback, UACR can be used as a BB for kidney outcomes to support registration of finerenone in type 1 diabetes, provided necessary criteria are met. Secondary outcomes include incidences of treatment-emergent adverse events, treatment-emergent serious adverse events and hyperkalaemia.
FINE-ONE will evaluate the efficacy and safety of finerenone in type 1 diabetes and CKD. Finerenone could become the first registered treatment for CKD associated with type 1 diabetes in almost 30 years.
Trial registration:ClinicalTrials.gov NCT05901831.</description><subject>Albuminuria</subject><subject>Chronic kidney disease</subject><subject>Finerenone</subject><subject>Type 1 diabetes</subject><issn>0168-8227</issn><issn>1872-8227</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNqFUctuGzEMFIoGqJvkEwLw2Mu6euzLvRRF4LQLBAlQJGdBlrg23Y12KykJ_FP5xsre3HsiQc5wSA5jV4IvBRf11_3SkdkEjEvJpVoKwVe8_cAWom1k0UrZfGSLjGtP-Sf2OcY957xWZbVgb79NotGbAcF4Bw4jbT2MPRgIuTA-UUQH085EhK7rIOCWYgonEqRAZgDyLxgTbXPNb6EnjwH96DE3YDIhkaXJ-BThldIO0mFCEHDcGBPGk6rdhdGThT_kPB5yL2LW-wYPO4Sb7m5d3N-tZ7ELdtabIeLlezxnjzfrh-tfxe39z-76x21hVSlT0aCtpOSV25TOqKbnzhquVLvqpVrJsqqsM6UoW1k6J2tpseeq2qxUWzfVpkanztmXee4Uxr_P-TydH2FxGIzH8Tlq2TalrEVdthlazVAbxhgD9noK9GTCQQuuj_7ovX73Rx_90bM_mfd95mG-44Uw6GgJvUVHAW3SbqT_TPgHfbaeHQ</recordid><startdate>202310</startdate><enddate>202310</enddate><creator>Heerspink, Hiddo J.L.</creator><creator>Birkenfeld, Andreas L.</creator><creator>Cherney, David Z.I.</creator><creator>Colhoun, Helen M.</creator><creator>Ji, Linong</creator><creator>Mathieu, Chantal</creator><creator>Groop, Per-Henrik</creator><creator>Pratley, Richard E.</creator><creator>Rosas, Sylvia E.</creator><creator>Rossing, Peter</creator><creator>Skyler, Jay S.</creator><creator>Tuttle, Katherine R.</creator><creator>Lawatscheck, Robert</creator><creator>Scott, Charlie</creator><creator>Edfors, Robert</creator><creator>Scheerer, Markus F.</creator><creator>Kolkhof, Peter</creator><creator>McGill, Janet B.</creator><general>Elsevier B.V</general><scope>6I.</scope><scope>AAFTH</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1136-8110</orcidid><orcidid>https://orcid.org/0000-0003-1407-9023</orcidid><orcidid>https://orcid.org/0000-0002-8345-3288</orcidid><orcidid>https://orcid.org/0000-0002-1531-4294</orcidid><orcidid>https://orcid.org/0000-0003-3425-7528</orcidid><orcidid>https://orcid.org/0000-0002-2235-0103</orcidid></search><sort><creationdate>202310</creationdate><title>Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial</title><author>Heerspink, Hiddo J.L. ; Birkenfeld, Andreas L. ; Cherney, David Z.I. ; Colhoun, Helen M. ; Ji, Linong ; Mathieu, Chantal ; Groop, Per-Henrik ; Pratley, Richard E. ; Rosas, Sylvia E. ; Rossing, Peter ; Skyler, Jay S. ; Tuttle, Katherine R. ; Lawatscheck, Robert ; Scott, Charlie ; Edfors, Robert ; Scheerer, Markus F. ; Kolkhof, Peter ; McGill, Janet B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c342t-7ec52205db4da37f0dca03389f2392455cda414824dd262cef035b938675b6ed3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Albuminuria</topic><topic>Chronic kidney disease</topic><topic>Finerenone</topic><topic>Type 1 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Heerspink, Hiddo J.L.</creatorcontrib><creatorcontrib>Birkenfeld, Andreas L.</creatorcontrib><creatorcontrib>Cherney, David Z.I.</creatorcontrib><creatorcontrib>Colhoun, Helen M.</creatorcontrib><creatorcontrib>Ji, Linong</creatorcontrib><creatorcontrib>Mathieu, Chantal</creatorcontrib><creatorcontrib>Groop, Per-Henrik</creatorcontrib><creatorcontrib>Pratley, Richard E.</creatorcontrib><creatorcontrib>Rosas, Sylvia E.</creatorcontrib><creatorcontrib>Rossing, Peter</creatorcontrib><creatorcontrib>Skyler, Jay S.</creatorcontrib><creatorcontrib>Tuttle, Katherine R.</creatorcontrib><creatorcontrib>Lawatscheck, Robert</creatorcontrib><creatorcontrib>Scott, Charlie</creatorcontrib><creatorcontrib>Edfors, Robert</creatorcontrib><creatorcontrib>Scheerer, Markus F.</creatorcontrib><creatorcontrib>Kolkhof, Peter</creatorcontrib><creatorcontrib>McGill, Janet B.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes research and clinical practice</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Heerspink, Hiddo J.L.</au><au>Birkenfeld, Andreas L.</au><au>Cherney, David Z.I.</au><au>Colhoun, Helen M.</au><au>Ji, Linong</au><au>Mathieu, Chantal</au><au>Groop, Per-Henrik</au><au>Pratley, Richard E.</au><au>Rosas, Sylvia E.</au><au>Rossing, Peter</au><au>Skyler, Jay S.</au><au>Tuttle, Katherine R.</au><au>Lawatscheck, Robert</au><au>Scott, Charlie</au><au>Edfors, Robert</au><au>Scheerer, Markus F.</au><au>Kolkhof, Peter</au><au>McGill, Janet B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial</atitle><jtitle>Diabetes research and clinical practice</jtitle><date>2023-10</date><risdate>2023</risdate><volume>204</volume><spage>110908</spage><epage>110908</epage><pages>110908-110908</pages><artnum>110908</artnum><issn>0168-8227</issn><eissn>1872-8227</eissn><abstract>PLS Type 1 diabetes is a condition where people have high blood sugar due to insufficient production of a protein called insulin. People with type 1 diabetes can often develop kidney disease. Eventually, their kidneys may stop working, resulting in the need for a procedure called dialysis which removes waste products from the body. In addition, people with type 1 diabetes and kidney disease are at higher risk of heart disease and tend to have a shorter life expectancy than people with type 1 diabetes without kidney disease. Here, the authors describe the design of a study in people with type 1 diabetes with kidney disease, called FINE-ONE. FINE-ONE is studying whether a drug called finerenone can slow down the progression of kidney disease. The FINE-ONE study will look at whether finerenone will reduce the amount of a protein called albumin in the urine. A high level of albumin in the urine is commonly recognized to be a sign of kidney disease. Reducing the amount of urine albumin with finerenone would show that finerenone can protect the kidneys of people with type 1 diabetes with kidney disease. If the study is successful, finerenone could be the first drug for kidney protection available to patients with type 1 diabetes in 30 years. Finerenone is already approved for the treatment of patients with type 2 diabetes and kidney disease.
[Display omitted]
•Finerenone is indicated for the treatment of chronic kidney disease (CKD) in type 2 diabetes.•The FINE-ONE clinical trial is investigating the effect of finerenone in people with type 1 diabetes and CKD.•The trial is investigating change in albuminuria from baseline over 6 months.•Albuminuria will be used as a bridging biomarker for regulatory approval purposes in type 1 diabetes and CKD.•Finerenone could become a new registered treatment for CKD progression in type 1 diabetes.
Despite guideline-recommended treatments, including renin angiotensin system inhibition, up to 40 % of individuals with type 1 diabetes develop chronic kidney disease (CKD) putting them at risk of kidney failure. Finerenone is approved to reduce the risk of kidney failure in individuals with type 2 diabetes. We postulate that finerenone will demonstrate benefits on kidney outcomes in people with type 1 diabetes.
FINE-ONE (NCT05901831) is a randomised, placebo-controlled, double-blind phase III trial of 7.5 months’ duration in ∼220 adults with type 1 diabetes, urine albumin/creatinine ratio (UACR) of ≥ 200–< 5000 mg/g (≥ 22.6–< 565 mg/mmol) and eGFR of ≥ 25–< 90 ml/min/1.73 m2.
The primary endpoint is relative change in UACR from baseline over 6 months. UACR is used as a bridging biomarker (BB), since the treatment effect of finerenone on UACR was associated with its efficacy on kidney outcomes in the type 2 diabetes trials. Based on regulatory authority feedback, UACR can be used as a BB for kidney outcomes to support registration of finerenone in type 1 diabetes, provided necessary criteria are met. Secondary outcomes include incidences of treatment-emergent adverse events, treatment-emergent serious adverse events and hyperkalaemia.
FINE-ONE will evaluate the efficacy and safety of finerenone in type 1 diabetes and CKD. Finerenone could become the first registered treatment for CKD associated with type 1 diabetes in almost 30 years.
Trial registration:ClinicalTrials.gov NCT05901831.</abstract><pub>Elsevier B.V</pub><doi>10.1016/j.diabres.2023.110908</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0003-1136-8110</orcidid><orcidid>https://orcid.org/0000-0003-1407-9023</orcidid><orcidid>https://orcid.org/0000-0002-8345-3288</orcidid><orcidid>https://orcid.org/0000-0002-1531-4294</orcidid><orcidid>https://orcid.org/0000-0003-3425-7528</orcidid><orcidid>https://orcid.org/0000-0002-2235-0103</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | Diabetes research and clinical practice, 2023-10, Vol.204, p.110908-110908, Article 110908 |
| issn | 0168-8227 1872-8227 |
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| source | Access via ScienceDirect (Elsevier) |
| subjects | Albuminuria Chronic kidney disease Finerenone Type 1 diabetes |
| title | Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial |
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