NIPH Clinical Trials Search

JRCT ID: jRCTs042180076

Registered date:11/03/2019


Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedDiabetic nephropathy
Date of first enrollment17/08/2015
Target sample size35
Countries of recruitment
Study typeInterventional
Intervention(s)LDL apheresis


Primary OutcomeProportion of patients with decreases of at least 30% in urinary protein/urinary creatinine ratio or urinary protein (daily amount with urinalysis) evaluated by 24-h urine collection 6 months from starting therapy
Secondary Outcome(1) Survival/kidney function maintenance rate* *Proportion of patients that did not result in death, dialysis introduction (kidney death), or doubled serum creatinine levels (2) Proportion of patients with decreases of at least 50% in urinary protein/urinary creatinine ratio or urinary protein (daily amount with urinalysis) (3) Serum creatinine decline speed (4) Proportion of cases with 1.5-fold increase or 1.3-fold increase in serum creatinine (5) Changes in QOL (SF-36) (6) Changes in clinical test values

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
Include criteria(1) Patients clinically diagnosed with DN in whom improvement was not noted with other treatments and who met the following clinical test result criteria. i) Urinary protein/urinary creatinine ratio of at least 3 g/g Cr or urinary protein (daily amount with urinalysis) of at least 3 g/day ii) Serum creatinine of below 2 mg/dL iii) Serum LDL cholesterol of at least 120 mg/dL with pharmacotherapy (2) Aged 20-75 years at time of giving consent (3) Patients who give consent themselves in writing
Exclude criteria(1) Patients receiving maintenance hemodialysis (2) Patients who have undergone kidney transplant or nephrectomy (3) Patients who have undergone LDL apheresis in the past (4) Patients who underwent some sort of blood purification therapy in the past 6 months (5) Patients who underwent surgical therapy including revascularization such as angioplasty or bypass surgery in the past 6 months (6) Patients with proliferative diabetic retinopathy (BI to BV according to New Fukuda classifications; however, excepting BI cases that have been determined by an ophthalmologist to be clinically stable). Alternatively, patients with diabetic neuropathy that is difficult to manage (7) Patients classified as Rutherford severity group 5 or greater, or patients with peripheral vascular disease who have undergone lower limb amputation (upper ankle) (8) Patients clinically diagnosed with primary glomerular nephritis or secondary nephrotic syndrome not caused by diabetes

Related Information


Public contact
Name Akihiro Inano
Address 1 Hikarigaoka Fukushima Fukushima Hukushima Japan 960-1295
Telephone +81-24-547-1774
Affiliation Fukushima Medical University Hospital
Scientific contact
Name Takashi Wada
Address 13-1 Takara-machi Kanazawa Ishikawa Ishikawa Japan 920-8641
Telephone +81-76-265-2000
Affiliation Kanazawa University Hospital