An open label multi facilities cooperation randomized control trial to verify renoprotective effects of pioglitazone therapy in diabetic nephropathy

An open label multi facilities cooperation randomized control trial to verify renoprotective effects of pioglitazone therapy in diabetic nephropathy - Pioglitazone Multicenter Intervention Clinical trial in Hospital of Tohoku region Improving Nephropathy, Oxidative stress, Kidney injury, Urinary albumin excretions (Pio-Michinoku study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001126

Enrollment

150

Registered

2008-04-30

Start date

2008-04-01

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

Type 2 diabetic nephropathy patients with chronic kidney disease (CKD)

Interventions

This study is a prospective randomized control trial. The entry period of this study is one year. Subjects were type 2 diabetics with nephropathy, taking RAS inhibitors. The patients were randomly ass

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects enrolled in the present study were type 2 diabetic out-patients with nephropathy, who visit our hospitals and fulfilled the following criteria:1) Mild or moderate hyperglycemia, defined as the HbA1c of 6.0-7.9 %. 2) Use of RAS inhibitors, such as an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II type-1 receptor blocker (ARB), for at least six months. 3) A urinary albumin-to-creatinine ratio (ACR) higher than 30 (mg/mgCr) (stage of diabetic nephropathy: stage II and higher).4) Not severe hypertension (blood pressure < 160/110 mmHg)

Exclusion criteria

Exclusion criteria: 1) A serum creatinine (Cr) level is more than 2.5 (mg/dl) and existence of hematuria.2) Patient who has received continuous dialysis.3) Severe diabetic complications such as retinal hemorrhage, neuropathy, and so on.4) Existence of severe hepatic damages, and cerebrovascular disorders including heart failure.5) Severe hypertension (BP>160/110 mmHg)6) Patients who judged that physician in charge is improper.

Design outcomes

Primary

Measure	Time frame
Estimated GFR decrease in 50% or more, increase of serum creatinine level to 3mg/dl or more, changes of urinary albumin excretion	—

Secondary

Measure	Time frame
Cardiovascular event: Appearance of disease of total death, nonfatal myocardial infarction (The asymptomatic cardiac infarction is included), and apoplexy, cerebral infarction, cardiac failure (BNP>1000pg/ml), and the serious illness edema	—

Countries

Japan

Contacts

Public ContactSusumu Ogawa

Tohoku University Hospital Division of Nephrology, Endocrinology and Hypertension

ogawa-s@hosp.tohoku.ac.jp022-717-7166

Outcome results

None listed

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