JPRN-jRCTs042180076Completed未知
clinical trial to assess the effects of LDL apheresis on proteinuria in diabetic patients with severe proteinuria and dyslipidemia - LICENSE study
Wada Takashi0 sites41 target enrollmentStarted: March 11, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 41
Study Overview
Brief Summary
DL apheresis was performed on 40 patients with diabetic nephropathy enrolled in this study. it was suggested that LDL apheresis for diabetic nephropathy presenting severe proteinuria with refractory hypercholesterolemia is useful for improving survival.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to <= 75age old (—)
- Sex
- All
Inclusion 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
Exclusion 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
Investigators
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