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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

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ClinicalTrials.gov Identifier: NCT01331317
Recruitment Status : Completed
First Posted : April 8, 2011
Last Update Posted : April 13, 2012
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Diabetic Nephropathy Drug: Paricalcitol Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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
Study Start Date : April 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Paricalcitol
Crossover study between paricalcitol and placebo
Drug: Paricalcitol
capsule, 1-2 micrograms daily for 90 days
Other Name: Zemplar




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

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


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331317


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

Responsible Party: Peter Rossing, Senior Physician, DMSc, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT01331317     History of Changes
Other Study ID Numbers: 2009-011255-44
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents