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Clinical Trial Details

Trial ID: L0398
Source ID: NCT00421733
Associated Drug: Zemplar (Paricalcitol ) Capsules
Title: The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors
Acronym: VITAL
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00421733/results
Conditions: Diabetic Nephropathy|Chronic Kidney Disease
Interventions: DRUG: Zemplar (paricalcitol ) capsules|DRUG: Zemplar (paricalcitol) capsules|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg)., UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis., Baseline (within 1 week prior to first treatment) through 24 weeks of treatment | Secondary: Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels., Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits., Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection., The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits., Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels., Change is mean change in picograms of iPTH per milliliter of serum., Baseline (screening period) through 24 weeks of treatment
Sponsor/Collaborators: Sponsor: Abbott
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 281
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2006-12
Completion Date: 2009-06
Results First Posted: 2010-09-14
Last Update Posted: 2012-01-20
Locations: Site Reference ID/Investigator# 862, Phoenix, Arizona, 85012, United States|Site Reference ID/Investigator# 864, Fountain Valley, California, 92708, United States|Site Reference ID/Investigator# 7291, Yuba City, California, 95991, United States|Site Reference ID/Investigator# 853, Hudson, Florida, 34667, United States|Site Reference ID/Investigator# 867, Lauderdale Lakes, Florida, 33313, United States|Site Reference ID/Investigator# 857, Pembroke Pines, Florida, 33028, United States|Site Reference ID/Investigator# 8901, West Palm Beach, Florida, 33401, United States|Site Reference ID/Investigator# 7113, Roswell, Georgia, 30076, United States|Site Reference ID/Investigator# 2531, Chicago, Illinois, 60654, United States|Site Reference ID/Investigator# 3371, Evanston, Illinois, 60201, United States|Site Reference ID/Investigator# 869, Indianapolis, Indiana, 46202, United States|Site Reference ID/Investigator# 8054, Baton Rouge, Louisiana, 70808, United States|Site Reference ID/Investigator# 854, Rockville, Maryland, 20852, United States|Site Reference ID/Investigator# 6281, Boston, Massachusetts, 02215, United States|Site Reference ID/Investigator# 859, Brooklyn Center, Minnesota, 55430, United States|Site Reference ID/Investigator# 7214, Omaha, Nebraska, 68131, United States|Site Reference ID/Investigator# 8046, Albany, New York, 12206, United States|Site Reference ID/Investigator# 866, Charlotte, North Carolina, 28208, United States|Site Reference ID/Investigator# 8039, Greenville, North Carolina, 27834, United States|Site Reference ID/Investigator# 8053, Morehead City, North Carolina, 28557, United States|Site Reference ID/Investigator# 6626, Winston-Salem, North Carolina, 27103, United States|Site Reference ID/Investigator# 7495, Carlisle, Pennsylvania, 17015, United States|Site Reference ID/Investigator# 9061, Dallas, Texas, 75230, United States|Site Reference ID/Investigator# 8325, Dallas, Texas, 75231, United States|Site Reference ID/Investigator# 856, Dallas, Texas, 75390, United States|Site Reference ID/Investigator# 7494, San Antonio, Texas, 78229, United States|Site Reference ID/Investigator# 774, San Antonio, Texas, 78229, United States|Site Reference ID/Investigator# 6316, Duesseldorf, 40210, Germany|Site Reference ID/Investigator# 5167, Hannover, 30625, Germany|Site Reference ID/Investigator# 6302, Ludwigshafen, 67059, Germany|Site Reference ID/Investigator# 6314, Athens, 18454, Greece|Site Reference ID/Investigator# 6306, Ioannina, 45500, Greece|Site Reference ID/Investigator# 5631, Thessaloniki, 54636, Greece|Site Reference ID/Investigator# 6310, Thessaloniki, 54642, Greece|Site Reference ID/Investigator# 6312, Bergamo, 24128, Italy|Site Reference ID/Investigator# 6303, Brescia, 25123, Italy|Site Reference ID/Investigator# 6309, Milan, 20142, Italy|Site Reference ID/Investigator# 6210, Modena, 41100, Italy|Site Reference ID/Investigator# 6207, Groningen, 9713 GZ, Netherlands|Site Reference ID/Investigator# 6304, Bydgoszcz, 85-094, Poland|Site Reference ID/Investigator# 5622, Katowice, 40027, Poland|Site Reference ID/Investigator# 5203, Szczecin, 70-111, Poland|Site Reference ID/Investigator# 6315, Warsaw, 00909, Poland|Site Reference ID/Investigator# 6327, Lisbon, 1069-166, Portugal|Site Reference ID/Investigator# 6326, Porto, 4202-451, Portugal|Site Reference ID/Investigator# 6916, Caguas, 00725, Puerto Rico|Site Reference ID/Investigator# 5175, Carolina, 00983, Puerto Rico|Site Reference ID/Investigator# 6290, Las Piedras, 00771, Puerto Rico|Site Reference ID/Investigator# 5179, Ponce, 00716, Puerto Rico|Site Reference ID/Investigator# 6293, Ponce, 00716, Puerto Rico|Site Reference ID/Investigator# 5173, Ponce, 00717-0634, Puerto Rico|Site Reference ID/Investigator# 6300, Ponce, 00717-1322, Puerto Rico|Site Reference ID/Investigator# 5168, Ponce, 00717-2075, Puerto Rico|Site Reference ID/Investigator# 7298, Rio Piedras, 00935, Puerto Rico|Site Reference ID/Investigator# 5170, San Juan, 00909, Puerto Rico|Site Reference ID/Investigator# 7509, San Juan, 00918, Puerto Rico|Site Reference ID/Investigator# 6288, San Juan, 00921-3201, Puerto Rico|Site Reference ID/Investigator# 6291, San Juan, 00936-5067, Puerto Rico|Site Reference ID/Investigator# 6919, Toa Baja, 00949, Puerto Rico|Site Reference ID/Investigator# 6296, Yabucoa, 00767, Puerto Rico|Site Reference ID/Investigator# 6569, Barcelona, 08036, Spain|Site Reference ID/Investigator# 10621, Galdakao, 48960, Spain|Site Reference ID/Investigator# 6330, L'Hospitalet de, 08907, Spain|Site Reference ID/Investigator# 5111, Madrid, 28041, Spain|Site Reference ID/Investigator# 5110, Oviedo, 33006, Spain|Site Reference ID/Investigator# 6329, Santander, 39008, Spain|Site Reference ID/Investigator# 11281, Valencia, 46017, Spain|Site Reference ID/Investigator# 6286, Hsin-Chuang City, Taiwan|Site Reference ID/Investigator# 8335, Taichung City, 40764, Taiwan|Site Reference ID/Investigator# 7927, Taichung, 433, Taiwan|Site Reference ID/Investigator# 6294, Taipei City, 10449, Taiwan|Site Reference ID/Investigator# 6285, Taipei, Taiwan
URL: https://clinicaltrials.gov/show/NCT00421733

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress