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.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT01331317
First received: July 27, 2010
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
UAER

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 October 23, 2014