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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 |
| 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 |
| Estimated 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:
However, subject may have switched to different brands but at equivalent doses during the three months prior to the Screening Phase.
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 71 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: | May 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00421733 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Type 2 Diabetic Nephropathy |
|
Renal Insufficiency Diabetic Nephropathies Albuminuria Urination Disorders Ergocalciferol Ergocalciferols Kidney Failure, Chronic Diabetes Mellitus Endocrine System Diseases Trace Elements Bone Density Conservation Agents Signs and Symptoms |
Proteinuria Vitamin D Vitamin D2 Urologic Diseases Renal Insufficiency, Chronic Vitamins Calciferol Micronutrients Endocrinopathy Kidney Diseases Diabetes Complications Kidney Failure |
|
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 |