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Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY

Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY - Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001324
Enrollment
100
Registered
2008-08-22
Start date
2008-08-01
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 with Hypercholesterolemia

Interventions

Pitavastatin treatment group Pravastatin treatment group

Sponsors

Kyushu University Graduate School of Medical Science Department of Medicine and Bioregulatory Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Type 2 diabetes patients with diabetic nephropathy and hypercholesterolemia fulfilling one or more of the following criteria 1) Biopsy-proven diabetic nephropathy 2) Duration of diabetes more than 5 years 3) Diabetic retinopathy 2.At least on two occasions during the observation period (0 month excluded), urinary albumin/ creatinine ratio in the range of 30-600mg/g. 3.Hypercholesterolemia 4.Over 20 years of age 5.Outpatient

Exclusion criteria

Exclusion criteria: 1."Contraindications""Relative Contraindications""Absolute Contraindications for Coadministration" and "Relative Contraindications for Coadministration" for pitavastatin or pravastatin 2.Patients with hypothyroidism or inherited muscle disorder (muscular dystrophy etc.) and patients with a previous history of drug-induced myopathy 3.Non- diabetic nephropathy 4. Renal dysfunction (s-Cr over 1.5 mg/dl) 5.Urinary tract infection 6.Uncontrolled diabetes, defined as HbA1c>10.0% 7.Malignancy 8. Stroke 9. Heart failure (NYHA Class >= III) or myocardial infarction 10.Angina with symptom 11.Participating in clinical trials or clinical research 12.Judged as unsuitable for participating in this study by the attending physician

Design outcomes

Primary

MeasureTime frame
Changes in urinary albumin/creatinine ratio,Changes in eGFR

Secondary

MeasureTime frame
urinary albumin/creatinine ratio, serum creatinine , Urea nitrogen, serum cystein C, LDL-C,TC,TG,HDL-C,non HDL-C, 8-isoprostane, urinary L-FABP, urinary typeIV collagen

Countries

Japan

Contacts

Public ContactToyoshi Inoguchi

Kyushu University Graduate School of Medical Science Department of Medicine and Bioregulatory Science

toyoshi@intmed3.med.kyushu-u.ac.jp092-642-5284

Outcome results

None listed

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