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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

Primary Purpose

Cardiovascular Disease, Diabetic Nephropathy

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Paricalcitol
Sponsored by
Peter Rossing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring Cardiovascular disease and mortality, Plasma NTproBNP, UAER

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Steno Diabetes Center A/S

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Paricalcitol

Arm Description

Crossover study between paricalcitol and placebo

Outcomes

Primary Outcome Measures

Change in plasma NT-proBNP

Secondary Outcome Measures

Change in Glomerular Filtration Rate (GFR)
Change in Urinary Albumin Excretion Rate

Full Information

First Posted
July 27, 2010
Last Updated
April 12, 2012
Sponsor
Peter Rossing
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT01331317
Brief Title
Effect of a Vitamin D Analogue vs Placebo on p-NT-proBNP in Patients With Type 1 DM and Diabetic Nephropathy
Official Title
The Effect of Paricalcitol Versus Placebo on Plasma N-Terminal-proBNP in Patients With Type 1 Diabetes Mellitus and Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Rossing
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Diabetic Nephropathy
Keywords
Cardiovascular disease and mortality, Plasma NTproBNP, UAER

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol
Arm Type
Other
Arm Description
Crossover study between paricalcitol and placebo
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Other Intervention Name(s)
Zemplar
Intervention Description
capsule, 1-2 micrograms daily for 90 days
Primary Outcome Measure Information:
Title
Change in plasma NT-proBNP
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Change in Glomerular Filtration Rate (GFR)
Time Frame
7 months
Title
Change in Urinary Albumin Excretion Rate
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise Tarnow, MD
Organizational Affiliation
Steno Diabetes Center A/S
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center A/S
City
Gentofte
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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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