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

Phase 4

Completed

• Conditions: Cardiovascular Disease; Diabetic Nephropathy
• Interventions: Drug: Paricalcitol

• Registration Number: NCT01331317
• Lead Sponsor: Peter Rossing

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-12
• Last Update Posted: 2012-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Paricalcitol	Paricalcitol	Crossover study between paricalcitol and placebo

Primary Outcome Measures

Name	Time	Method
Change in plasma NT-proBNP	7 months

Secondary Outcome Measures

Name	Time	Method
Change in Glomerular Filtration Rate (GFR)	7 months
Change in Urinary Albumin Excretion Rate	7 months

Trial Locations

Locations (1)

Steno Diabetes Center A/S; 🇩🇰 Gentofte, Denmark