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

Study Overview
=================
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.

Official Title
-----------------
The Effect of Paricalcitol Versus Placebo on Plasma N-Terminal-proBNP in Patients With Type 1 Diabetes Mellitus and Diabetic Nephropathy

Conditions
-----------------
Diabetic Nephropathy, Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: Paricalcitol


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Paricalcitol<br>Crossover study between paricalcitol and placebo | Drug: Paricalcitol<br>* capsule, 1-2 micrograms daily for 90 days<br>* Other names: Zemplar;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma NT-proBNP |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glomerular Filtration Rate (GFR) |  | 7 months | 
| Change in Urinary Albumin Excretion Rate |  | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular disease and mortality, Plasma NTproBNP, UAER