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| Sponsor: | 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 and 4 |
Drug: Zemplar (paricalcitol ) capsules Drug: Zemplar (paricalcitol) capsules Drug: Placebo |
Phase II |
| 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 |
| Enrollment: | 281 |
| Study Start Date: | February 2007 |
| Primary Completion Date: | May 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
|
Drug: Zemplar (paricalcitol ) capsules
Group 2 - paricalcitol capsules 1 mcg QD (one paricalcitol 1 mcg QD capsule and one matching placebo capsule QD)
|
|
Paricalcitol 2 mcg: Active Comparator
Two paricalcitol 1 mcg capsules per dose
|
Drug: Zemplar (paricalcitol) capsules
Group 3 - paricalcitol capsules 2 mcg QD (two paricalcitol 1 mcg capsules QD)
|
|
Placebo: Placebo Comparator
Two placebo capsules per dose
|
Drug: Placebo
Group 1 - Placebo QD (two placebo capsules QD)
|
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
Show 70 Study Locations| Study Director: | Paul Audhya, MD | Abbott |
More Information
| Responsible Party: | Abbott ( Dennis Andress, MD ) |
| Study ID Numbers: | M05-741, EudraCT: 2006-001363-31 |
| Study First Received: | January 10, 2007 |
| Last Updated: | July 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00421733 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Type 2 Diabetic Nephropathy |
|
Renal Insufficiency Albuminuria Diabetic Nephropathies Urination Disorders Growth Substances Physiological Effects of Drugs Ergocalciferols Kidney Failure, Chronic Diabetes Mellitus Endocrine System Diseases Bone Density Conservation Agents |
Pharmacologic Actions Urological Manifestations Signs and Symptoms Proteinuria Urologic Diseases Renal Insufficiency, Chronic Vitamins Micronutrients Kidney Diseases Diabetes Complications Kidney Failure |