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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 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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 Peter Rossing, Steno Diabetes Center:

Primary Outcome Measures:
  • Change in plasma NT-proBNP [ Time Frame: 7 months ]

Secondary Outcome Measures:
  • Change in Glomerular Filtration Rate (GFR) [ Time Frame: 7 months ]
  • Change in Urinary Albumin Excretion Rate [ Time Frame: 7 months ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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 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 Identifier: NCT01331317     History of Changes
Other Study ID Numbers: 2009-011255-44
Study First Received: July 27, 2010
Last Updated: April 12, 2012

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on August 22, 2017