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

NCT01331317 | Completed Phase 4 DMC

• 1 other identifier: 2009-011255-44
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Diabetic Nephropathy

Keywords

Cardiovascular disease and mortality; Plasma NTproBNP; UAER

Outcome Measures

Primary Outcomes (1)

• Change in plasma NT-proBNP

  7 months

Secondary Outcomes (2)

• Change in Glomerular Filtration Rate (GFR)

  7 months

• Change in Urinary Albumin Excretion Rate

  7 months

Study Arms (1)

Paricalcitol

OTHER

Crossover study between paricalcitol and placebo

Drug: Paricalcitol

Interventions

Paricalcitol DRUG

capsule, 1-2 micrograms daily for 90 days

Also known as: Zemplar

Paricalcitol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter Rossing: lead
• Abbott: collaborator

Study Sites (1)

Steno Diabetes Center A/S

Gentofte Municipality, 2400, Denmark

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetic Nephropathies

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Lise Tarnow, MD

  Steno Diabetes Center A/S

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Physician, DMSc

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: April 8, 2011
• Study Start: April 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 13, 2012

Record last verified: 2012-04

Locations

DK (1)