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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331317
• Other study ID #: 2009-011255-44
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2010
• Last updated: April 12, 2012
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Steno Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Paricalcitol
capsule, 1-2 micrograms daily for 90 days

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center A/S	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
Peter Rossing	Abbott

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma NT-proBNP		7 months	No
Secondary	Change in Glomerular Filtration Rate (GFR)		7 months	No
Secondary	Change in Urinary Albumin Excretion Rate		7 months	No