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

The Effect of Paricalcitol Versus Placebo on Plasma N-Terminal-proBNP in Patients With Type 1 Diabetes Mellitus and Diabetic Nephropathy

Sponsors

Lead Sponsor: Peter Rossing

Collaborator: Abbott

Source Steno Diabetes Center Copenhagen
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.

Overall Status Completed
Start Date April 2010
Completion Date April 2012
Primary Completion Date April 2012
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in plasma NT-proBNP 7 months
Secondary Outcome
Measure Time Frame
Change in Glomerular Filtration Rate (GFR) 7 months
Change in Urinary Albumin Excretion Rate 7 months
Enrollment 48
Condition
Intervention

Intervention Type: Drug

Intervention Name: Paricalcitol

Description: capsule, 1-2 micrograms daily for 90 days

Arm Group Label: Paricalcitol

Other Name: Zemplar

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Lise Tarnow, MD Principal Investigator Steno Diabetes Center A/S
Location
Facility: Steno Diabetes Center A/S
Location Countries

Denmark

Verification Date

April 2012

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Steno Diabetes Center Copenhagen

Investigator Full Name: Peter Rossing

Investigator Title: Senior Physician, DMSc

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Paricalcitol

Type: Other

Description: Crossover study between paricalcitol and placebo

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov