Effect of a Vitamin D Analogue vs Placebo on p-NT-proBNP in Patients With Type 1 DM and Diabetic Nephropathy

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter Rossing
• Collaborator: Abbott
• Treatments: Ergocalciferols

Criteria

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.