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

Peter Rossing1 site in 1 country48 target enrollmentApril 2010

ConditionsCardiovascular Disease Diabetic Nephropathy

InterventionsParicalcitol

DrugsParicalcitol

Overview

Phase: Phase 4
Intervention: Paricalcitol
Conditions: Cardiovascular Disease
Sponsor: Peter Rossing
Enrollment: 48
Locations: 1
Primary Endpoint: Change in plasma NT-proBNP
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

April 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Peter Rossing

Responsible Party

Sponsor Investigator

Principal Investigator

Peter Rossing

Senior Physician, DMSc

Steno Diabetes Center Copenhagen

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