Patients with mild to moderate chronic renal failure (CRF
Conditions
Interventions
Trade Name: Zemplar
Product Name: Zemplar
Pharmaceutical Form: Capsule*
INN or Proposed INN: paricalcitol
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
Pharmac
Sponsors
Karolinska Institutet at Danderyd University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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+ 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The major goal of this study is to develop an enhanced understanding of the disturbances involved in how a progressive loss of kidney function cause increased cardiovascular disturbance, disease and ultimately death, and if some of these disturbances can be ameliorated and modified by treatment with a VDRA. Furthermore, evidence suggest that Diabetic kidney disease constitute a separate entity with certain characteristics that may respond differently to treatment with VDRA. Thus we intend to compare diabetic kidney disease with non-diabetic. As kidney disease is characterized by increased neurohormonal activation and sympathetic overactivity, the primary outcome variable will be a change (reduction) in sympathetic activity as measured by a tungsten microelectrode inserted percutaneously into a fascicle of the peroneal nerve at the level of the fibular head (muscle sympathetic nerve activity: MSNA). ;Secondary Objective: A) To determine whether sympathetic overactivity cause sympathovagal imbalance, reflected in altered heart rate variability, disturbed baroreflex regulation, and altered transfer-function between blood pressure and sympathetic nerve activity? May these disturbances be ameliorated by treatment with VDRA? B)Endothelial dysfunction and increased arterial stiffness are common features in severe renal failure, and have been shown even before diagnosis in DM-II. To which degrees are they present in mild to moderate CKD, and how do they correlate with other physiological changes? May these disturbances be modified by treatment with VDRA? C/Several factors involved in haemostasis and inflammation are independent risk factors for mortality in patients with end stage renal disease. Is the haemostasis disturbed in mild to moderate CKD, and if so, is this correlated to sympathetic activation and impaired microcirculatory control? May these disturbances be ameliorated by treatment with VDRA?;Primary end point(s): Sympathetic activation measured by | — |
Countries
Sweden
Outcome results
None listed