Apararenone in patients with diabetic nephropathy: results of a randomized, double-blind, placebo-controlled phase 2 dose-response study and open-label extension study
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Background: We investigated the efficacy and safety of apararenone (MT-3995), a non-steroidal compound with mineralocorticoid receptor agonist activity, in patients with stage 2 diabetic nephropathy (DN). Methods: The study had two parts: a dose–response, parallel-group, randomized, double-blind, placebo-controlled, multicenter, phase 2, 24-week study and an open-label, uncontrolled, 28-week extension study. Primary and secondary endpoints were the 24-week percent change from baseline in urine albumin to creatine ratio (UACR) and 24- and 52-week UACR remission rates. Safety parameters were changes from baseline in estimated glomerular filtration rate (eGFR) and serum potassium at 24 and 52 weeks, and incidences of adverse events (AEs) and adverse drug reactions (ADRs). Results: In the dose–response period, 73 patients received placebo and 73, 74, and 73 received apararenone 2.5 mg, 5 mg, and 10 mg, respectively. As a percentage of baseline, mean UACR decreased to 62.9%, 50.8%, and 46.5% in the 2.5 mg, 5 mg, and 10 mg apararenone groups, respectively, at week 24 (placebo: 113.7% at week 24; all P < 0.001 vs placebo). UACR remission rates at week 24 were 0.0%, 7.8%, 29.0%, and 28.1% in the placebo and apararenone 2.5 mg, 5 mg, and 10 mg groups, respectively. eGFR tended to decrease and serum potassium tended to increase, but these events were not clinically significant. AE incidence increased with dose while ADR incidence did not. Conclusion: The UACR-lowering effect of apararenone administered once daily for 24 weeks in patients with stage 2 DN was confirmed, and the 52-week administration was safe and tolerable. Clinical trial registration: NCT02517320 (dose–response study) and NCT02676401 (extension study)
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The updated evidence review identified 27 RCTs on MRA, with 5 RCTs comparing nonsteroidal MRA to placebo and/or standard of care.
“Overall, the updated evidence review identifi ed 27 RCTs on MRA, with 5 RCTs comparing nonsteroidal MRA to placebo and/or standard of care.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [175]
The Introduction describes apararenone as a nonsteroidal MRA investigated against placebo, and Results > Participants reports random assignment to placebo or apararenone groups. This establishes one qualifying trial, but the paper does not report an updated evidence review or substantiate the counts of 27 RCTs and five nonsteroidal-MRA RCTs. Page numbers are unavailable in our copy. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn outcomes that only included the smaller trials, methodological limitations due to uncertainty in reporting of allocation concealment were evident.
“In outcomes that only included the smaller trials, 166,167,175 methodological limitations due to uncertainty in reporting of allocation concealment were evident.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [175]
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- Authors
- Wada, T., Inagaki, M., Yoshinari, T., Terata, R., Totsuka, N., Gotou, M., & Hashimoto, G.
- Affiliations
- Kanazawa University (JP)
- Tanabe Pharma Corporation (Japan) (JP)
- Corresponding author
- Hashimoto, Gaia
- ORCID
- Wada, Takashi
- Venue
- Clinical and Experimental Nephrology
- Published
- 2020-09-24
- Volume
- 25
- Issue
- 2
- Pages
- 120-130
- ISSN
- 1342-1751 (ISSN-L)
- 1437-7799
- PMC
- PMC7880964
- OpenAlex
- W3088912120
- Cited by
- 97
- References
- 23
- Citations by year
- 2026: 15 · 2025: 11 · 2024: 22 · 2023: 15 · 2022: 21 · 2021: 13
- FWCI
- 7.86
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Clinical and Experimental Nephrology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Mitsubishi Tanabe Pharma Corporation.
- Topics
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
- Health Sciences › Medicine › Nephrology › Renal Diseases and Glomerulopathies
- Keywords
- diabetic nephropathy, dose-response relationship, estimated glomerular filtration rate, serum potassium, drug safety and tolerability
- MeSH terms
- Adult, Aged, Albuminuria, Mineralocorticoid Receptor Antagonists, Creatinine, Diabetic Nephropathies, Dose-Response Relationship, Drug, Double-Blind Method, Female, Glomerular Filtration Rate, Humans, Male, Middle Aged, Oxazines, Sulfonamides, Young Adult
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