LICENSE study

JRCT ID: jRCTs042180076

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetic nephropathy
• Date of first enrollment: 17/08/2015
• Target sample size: 35
• Study type: Interventional
• Intervention(s): LDL apheresis

Outcome(s)

• Primary Outcome: Proportion 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
• Gender: Both

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

• Primary Sponsor: Wada Takashi
• Source(s) of Monetary Support: Hokuriku Clinical Research Supporting Center; HEART
• Secondary ID(s): UMIN000014875