A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven PhaseIII study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease insubjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease

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    Recruiting
Updated on 23 November 2020

Summary

A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven PhaseIII study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease insubjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease

Description

Demonstrate whether finerenone is superior to placebo in delaying the progression of kidney disease. Randomized at 1:1 ratio. Subjects will take one pill once a day.

Participants will receive $85 per visit.

Details
Condition Diabetic Kidney Disease
Clinical Study IdentifierTX143053
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Type 2 Diabetes
Subjects with a clinical diagnosis of DKD based on either of the following criteria at the Run-in and Screening Visit
Persistent high albuminuria defined as UACR of ≥ 30mg/g but <300mg/g and eGFR of ≤ 25 but <60 mL/min/1.73m2 and presence of diabetic retinopathy in medical history
OR
Persistent very high albuminuria defined as UACR of ≥ 300 mg/g (≥33.9mg/mmol) and eGFR ≥25 but < 75 mL/min/1.73 m2

Exclusion Criteria

Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
HbA1c > 12% (>108 mmol/mol) at the Run-in Visit or Screening Visit
Addison’s Disease
Hepatic insufficiency classified as Child-Pugh
Dialysis for acute renal failure within 12 weeks prior to the Run-in Visit
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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