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

This study has been completed.
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center
ClinicalTrials.gov Identifier:
First received: July 27, 2010
Last updated: April 12, 2012
Last verified: April 2012
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.

Condition Intervention Phase
Cardiovascular Disease
Diabetic Nephropathy
Drug: Paricalcitol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Paricalcitol Versus Placebo on Plasma N-Terminal-proBNP in Patients With Type 1 Diabetes Mellitus and Diabetic Nephropathy

Resource links provided by NLM:

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • Change in plasma NT-proBNP [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Glomerular Filtration Rate (GFR) [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Change in Urinary Albumin Excretion Rate [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: April 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Crossover study between paricalcitol and placebo
Drug: Paricalcitol
capsule, 1-2 micrograms daily for 90 days
Other Name: Zemplar


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01331317

Steno Diabetes Center A/S
Gentofte, Denmark, 2400
Sponsors and Collaborators
Peter Rossing
Principal Investigator: Lise Tarnow, MD Steno Diabetes Center A/S
  More Information

Responsible Party: Peter Rossing, Senior Physician, DMSc, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT01331317     History of Changes
Other Study ID Numbers: 2009-011255-44 
Study First Received: July 27, 2010
Last Updated: April 12, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Steno Diabetes Center:
Cardiovascular disease and mortality
Plasma NTproBNP

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 27, 2016