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:
Peter Rossing
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
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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 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 Diabetes Mellitus, Type 1 Diabetic Nephropathies Kidney Diseases Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Urologic Diseases Diabetes Complications Ergocalciferols Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013