Clinical trial NCT01331317: Effect of a Vitamin D Analogue vs Placebo on p-NT-proBNP in Patients With Type 1 DM and Diabetic Nephropathy
Official title: The Effect of Paricalcitol Versus Placebo on Plasma N-Terminal-proBNP in Patients With Type 1 Diabetes Mellitus and Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
Diabetic Nephropathy
Keywords: Cardiovascular disease and mortality
Plasma NTproBNP
UAER
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2011-04-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in plasma NT-proBNP
timeFrame: 7 months
Secondary outcomes:
measure: Change in Glomerular Filtration Rate (GFR)
timeFrame: 7 months
measure: Change in Urinary Albumin Excretion Rate
timeFrame: 7 months
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center A/S
Study officials:
affiliation: Steno Diabetes Center A/S
name: Lise Tarnow, MD
role: PRINCIPAL_INVESTIGATOR
References: