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| Sponsored by: |
Abbott |
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00421733 |
Purpose
The study objective is to evaluate the effect of paricalcitol capsules on albuminuria reduction in Chronic Kidney Disease (CKD) subjects with Type 2 diabetic nephropathy receiving optimal ACEi and/or ARB therapy
| Condition | Intervention | Phase |
|
Diabetic Nephropathy Chronic Kidney Disease Stages 3 & 4 |
Drug: Zemplar (paricalcitol ) capsules Drug: Zemplar (paricalcitol) capsules Drug: Placebo |
Phase II |
| MedlinePlus related topics: | Diabetic Kidney Problems |
| ChemIDplus related topics: | Vitamin D Ergocalciferol 19-Nor-1alpha,25-dihydroxyvitamin D2 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | VITAL Study - Selective VITamin D Receptor Activator (Paricalcitol) for Albuminuria Lowering Study: A Phase 2, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Subjects Who Are Currently Being Treated With Renin-Angiotensin System Inhibitors |
| Estimated Enrollment: | 258 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
Paricalcitol 1 mcg: Active Comparator
One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
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Drug: Zemplar (paricalcitol ) capsules
Group 2 - paricalcitol capsules 1 mcg QD (one paricalcitol 1 mcg QD capsule and one matching placebo capsule QD)
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Paricalcitol 2 mcg: Active Comparator
Two paricalcitol 1 mcg capsules per dose
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Drug: Zemplar (paricalcitol) capsules
Group 3 - paricalcitol capsules 2 mcg QD (two paricalcitol 1 mcg capsules QD)
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Placebo: Placebo Comparator
Two placebo capsules per dose
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Drug: Placebo
Group 1 - Placebo QD (two placebo capsules QD)
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Eligibility
| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For entry into the Treatment Phase the subject must satisfy the following criteria based on the Screening laboratory values:
Exclusion Criteria:
Contacts and Locations| Contact: Mark Holst | 847-936-0809 | mark.holst@abbott.com |
| Contact: Dennis Andress, MD | 847-936-3555 | dennis.andress@abbott.com |
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Show 71 Study Locations |
| Abbott |
| Study Director: | Paul Audhya, MD | Abbott |
More Information
| Responsible Party: | Abbott ( Dennis Andress, MD ) |
| Study ID Numbers: | M05-741, EudraCT: 2006-001363-31 |
| First Received: | January 10, 2007 |
| Last Updated: | September 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00421733 |
| Health Authority: | United States: Food and Drug Administration |
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