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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiovascular Disease Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paricalcitol

Crossover study between paricalcitol and placebo

Group Type OTHER

Paricalcitol

Intervention Type DRUG

capsule, 1-2 micrograms daily for 90 days

Interventions

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Paricalcitol

capsule, 1-2 micrograms daily for 90 days

Intervention Type DRUG

Other Intervention Names

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Zemplar

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No