Sympathetic activation, microcirculation, haemostasis and inflammation in diabetic and non-diabetic kidney disease: disease modification by vitamin D receptor activation - VDRA and CKD

Karolinska Institutet at Danderyd University Hospital0 个研究点开始时间: 2009年9月22日最近更新: 2012年3月19日

试验速览

暂无简介。

•Man or woman above 20 years of age.
•If woman in reproductive age: not nursing and not pregnant (preseting a negative pregnancy test), and on anticonception therapy.
•Calculated GFR between 15-59 mL/min/1.73m2 using MDRD
•S-Ca2+ <2.6 mmol/L
•iPTH between 35-500 pg/mL
•Serum albumin > 3.0 g/dL
•Signed informed consent
•For inclusion in the diabetes study group:
•Diagnosed type II diabetes, and treated with peroral antidiabetics or insulin the last 12 months
•HbA1c <= 12%
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Changes in ACE-inhibitor medication or ARB within 8 weeks before start of the study.
•Nefrotic syndrome
•Expected need for dialysis within 6 months after study start
•Vitamin D treatment within 6 months before start of the study.
•Poorly controlled hypertension with blood pressure >150/100 mmHg (repeated measurements after 15 minutes rest)
•Concomitant treatment with drugs affecting bone and calcium metabolism such as kalcitonin, cinacalcet (Mimpara or Parareg), and high dose corticosteroids.
•Concomitant treatment with drugs inhibiting or inducing Cytokrom P450 3A.
•Known hypersensitivity to any of the substances in study drug or placebo.
•Diabetic nefropathy and concurrent glomerulonefritis or nefritis
•Acute renal failure within 12 weeks before screening
•Other severe chronic disease (AIDS/HIV-positive, cancer, severe heart failure etc.)
•Known kidney artery stenosis
•Known kidney stone disease
•Intake of other investigational medicinal product within 30 days before screening.
•Known alcohol or drug abuse
•Known low compliance
•Not suitable for participation for other reason according to investigators opinion.

发起方

Karolinska Institutet at Danderyd University Hospital