Cardiovascular Disease, Diabetic Nephropathy
Conditions
Keywords
Cardiovascular disease and mortality, Plasma NTproBNP, UAER
Brief summary
The primary objective is to assess the impact of three months of treatment with an active vitamin D analogue on a risk marker for excess overall mortality and cardiovascular morbidity/mortality in Type 1 diabetic patients with diabetic kidney disease. The hypothesis is that active vitamin D analogue treatment reduces the risk of cardiovascular morbidity and mortality in patients with type 1 diabetic kidney disease.
Interventions
DRUGParicalcitol
capsule, 1-2 micrograms daily for 90 days
Sponsors
Abbott
Peter Rossing
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18-75 years of age * Type 1 diabetes mellitus * Diabetic nephropathy (defined by persistent albuminuria, \> 300 mg/24 hr or 200µg/min in 2 of 3 consecutive samples, presence of diabetic retinopathy and absence of clinical or laboratory evidence of other kidney or renal tract disease * Chronic kidney disease stage 3 and 4 * S-Parathyroid hormone (s-PTH)\> 35pg/ml * Stabile RAAS-blocking and diuretic treatment
Exclusion criteria
* Other kidney disease than diabetic nephropathy * Myocardial infarction within the last three months prior to visit 1 * Coronary artery revascularization within the last three months prior to visit 1 * Transitional cerebral ischemia (TCI) or apoplexia within the last three months prior to visit 1 * Cardiac Failure (NYHA Class III or IV) * Kidney Failure (GFR \<15ml/min), dialysis, kidney transplantation) * Liver disease with serum alanine aminotransferase (ALT\>3 x the normal value * Alcohol/drug abuse * Hypercalcemia (serum ionized calcium \>1.35 mmol /L) * Medication with phosphate and/or vitamin D-containing medications, which can not be paused during the study * Clinical signs of vitamin D toxicity * Pregnant or nursing women * Fertile women not using chemical or mechanical (IUD) contraceptive methods * Current disulfiram treatment * Allergy to the study drug * Patient unable to understand the informed consent * Any other condition or therapy which, in the opinion of the investigator, makes the patient not suited for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in plasma NT-proBNP | 7 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Glomerular Filtration Rate (GFR) | 7 months |
| Change in Urinary Albumin Excretion Rate | 7 months |
Countries
Denmark
Outcome results
None listed