Skip to content

Effects of Additional Spironolactone on Persistent Proteinuria After SGLT2 Inhibitor Therapy in Patients with Diabetic Kidney Disease

Effects of Additional Spironolactone on Persistent Proteinuria After SGLT2 Inhibitor Therapy in Patients with Diabetic Kidney Disease - Effects of Additional Spironolactone on Persistent Proteinuria After SGLT2 Inhibitor Therapy in Patients with Diabetic Kidney Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000060242
Enrollment
29
Registered
2026-03-01
Start date
2023-11-07
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type-2 diabetes

Interventions

None listed

Sponsors

Jinnouchi Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: stable adult T2DM patients demonstrated persistent proteinuria (UPCR; A2 to A3; >0.15 g/gCre) despite more than 6 months of SGLT2i therapy (dapagliflozin; 10 mg/day) at the outpatient's department in Jinnouchi Hospital between January 2019 and July 2022 and initiated additional spironolactone therapy (initial dose; 12.5 mg/day). Patients were included if levels of proteinuria and eGFR measurements were performed both before and after the initiation of spironolactone and follow-up periods were 12 months.

Exclusion criteria

Exclusion criteria: Patients with hyperkalemia (K>5.5), cancer, severe infection, recent cardiovascular events, heart failure (New York Heart Association class III or higher), advanced chronic kidney disease (eGFR<15 mL/min/1.73 m2), advanced hepatic diseases, or concomitant use of eplerenone were excluded.

Design outcomes

Primary

MeasureTime frame
The primary endpoint was spironolactone therapy-induced changes in urinary protein-to-creatinine ratio (UPCR) levels.

Secondary

MeasureTime frame
The secondary outcome was the spironolactone treatment-induced changes in the annual rate of eGFR decline.

Countries

Japan

Contacts

Public ContactSeigo Sugiyama

Jinnouchi Hospital Diabetes Care Center

seigosugiyama@jinnouchi.or.jp0963630011

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026