A randomized, placebo-controlled double-blind, study evaluating the effect of pirfenidone in patients with chronic kidney disease and diabetes mellitus

A randomized, placebo-controlled double-blind, study evaluating the effect of pirfenidone in patients with chronic kidney disease and diabetes mellitus - Effect of pirfenidone on kidney function in patients with diabetic renal disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014967

Enrollment

Registered

2014-08-27

Start date

2014-08-27

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Chronic kidney disease patients associated with diabetes mellitus

Interventions

placebo pirfenidone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Diabetic nephropathy patients whose diabetic stage is IIIa, IIIb or IV and CKD stage is G3a or G3b. 2)eGFR >=30 and <60 mL/min/1.73 m2 3)Treatment with ACEI and/or ARB for 3 months prior to the first dosing of investigational drug. 4)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Items prohibited in pirfenidone package insert 2)History of allergy to lactose used as placebo 3)Investigator concludes that the patient's participation in this study is inappropriate

Design outcomes

Primary

Measure	Time frame
Change of inulin clearance, serum creatinine, eGFR, and albumin-to-creatinine ratio from baseline to end of treatment	—

Countries

Japan

Contacts

Public ContactYoshinari Tsuruta

Meiyo Clinic, Hemodialysis Center nephrology

y-tsuruta@yahoo.co.jp0532-33-3130

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026