| January 10, 2007 |
| July 13, 2009 |
| February 2007 |
| May 2009 (final data collection date for primary outcome measure) |
| The percent change from baseline to the last on-treatment UACR measurement using UACR levels determined from the first morning void urine collections [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ] |
| The percent change from baseline to the last on-treatment UACR levels using UACR levels determined from the first morning void urine collections |
| Complete list of historical versions of study NCT00421733 on ClinicalTrials.gov Archive Site |
- The proportion of subjects achieving at least a 15% reduction in the last on-treatment UACR levels from baseline; the change from baseline to the last on-treatment measurement in albumin determined from 24-hour urine collections. [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
- The change from baseline to the last on-treatment measurement in albumin determined from 24-hour urine collections [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
|
- The proportion of subjects achieving at least a 15% reduction in the last on-treatment UACR levels from baseline
- The change from baseline to the last on-treatment measurement in albumin determined from 24-hour urine collections
|
| |
| A Study of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors |
| 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 |
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 |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- Diabetic Nephropathy
- Chronic Kidney Disease Stages 3 and 4
|
- Drug: Zemplar (paricalcitol ) capsules
- Drug: Zemplar (paricalcitol) capsules
- Drug: Placebo
|
- Active Comparator: One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
- Active Comparator: Two paricalcitol 1 mcg capsules per dose
- Placebo Comparator: Two placebo capsules per dose
|
| |
| |
| Completed |
| 281 |
|
| May 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
- Subject has previously been on prescription-based vitamin D therapy within the six months prior to the Screening Phase.
- Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
- Subject has primary glomerulonephritis or secondary nephritis in addition to diabetic nephropathy.
- Subject has had acute renal failure within 12 weeks of the Screening Phase.
- Subject has chronic gastrointestinal disease.
- Subject has secondary hypertension.
- Subject has poorly controlled hypertension.
- Subject has a history of kidney stones.
- Subject has a history of drug or alcohol abuse within six months prior to the Screening Phase.
- Subject has evidence of poor compliance with diet or medication.
- Subject has received any investigational drug within 30 days prior to study drug administration.
- Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical glucocorticoids), or other drugs that may affect calcium or bone metabolism, other than calcium containing phosphate binder or female subjects on stable (same dose and product for three months) estrogen and/or progestin therapy.
- For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules or is put at risk by study procedures.
- Subject is known to be HIV positive.
- Use of known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration.
|
| Both |
| 20 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Germany, Greece, Italy, Netherlands, Poland, Portugal, Puerto Rico, Spain, Taiwan |
| |
| NCT00421733 |
| Dennis Andress, MD, Abbott |
| M05-741, EudraCT: 2006-001363-31 |
| Abbott |
|
| Study Director: |
Paul Audhya, MD |
Abbott |
|
|
| Abbott |
| July 2009 |