- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00421733
The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors (VITAL)
January 18, 2012 updated by: Abbott
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 was to evaluate the safety of paricalcitol capsules and the efficacy of paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD) who have Type 2 diabetic nephropathy and are receiving optimal angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB) therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
281
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Duesseldorf, Germany, 40210
- Site Reference ID/Investigator# 6316
-
Hannover, Germany, 30625
- Site Reference ID/Investigator# 5167
-
Ludwigshafen, Germany, 67059
- Site Reference ID/Investigator# 6302
-
-
-
-
-
Athens, Greece, 18454
- Site Reference ID/Investigator# 6314
-
Ioannina, Greece, 45500
- Site Reference ID/Investigator# 6306
-
Thessaloniki, Greece, 54636
- Site Reference ID/Investigator# 5631
-
Thessaloniki, Greece, 54642
- Site Reference ID/Investigator# 6310
-
-
-
-
-
Bergamo, Italy, 24128
- Site Reference ID/Investigator# 6312
-
Brescia, Italy, 25123
- Site Reference ID/Investigator# 6303
-
Milan, Italy, 20142
- Site Reference ID/Investigator# 6309
-
Modena, Italy, 41100
- Site Reference ID/Investigator# 6210
-
-
-
-
-
Groningen, Netherlands, 9713 GZ
- Site Reference ID/Investigator# 6207
-
-
-
-
-
Bydgoszcz, Poland, 85-094
- Site Reference ID/Investigator# 6304
-
Katowice, Poland, 40027
- Site Reference ID/Investigator# 5622
-
Szczecin, Poland, 70-111
- Site Reference ID/Investigator# 5203
-
Warsaw, Poland, 00909
- Site Reference ID/Investigator# 6315
-
-
-
-
-
Lisbon, Portugal, 1069-166
- Site Reference ID/Investigator# 6327
-
Porto, Portugal, 4202-451
- Site Reference ID/Investigator# 6326
-
-
-
-
-
Caguas, Puerto Rico, 00725
- Site Reference ID/Investigator# 6916
-
Carolina, Puerto Rico, 00983
- Site Reference ID/Investigator# 5175
-
Las Piedras, Puerto Rico, 00771
- Site Reference ID/Investigator# 6290
-
Ponce, Puerto Rico, 00716
- Site Reference ID/Investigator# 5179
-
Ponce, Puerto Rico, 00716
- Site Reference ID/Investigator# 6293
-
Ponce, Puerto Rico, 00717-0634
- Site Reference ID/Investigator# 5173
-
Ponce, Puerto Rico, 00717-1322
- Site Reference ID/Investigator# 6300
-
Ponce, Puerto Rico, 00717-2075
- Site Reference ID/Investigator# 5168
-
Rio Piedras, Puerto Rico, 00935
- Site Reference ID/Investigator# 7298
-
San Juan, Puerto Rico, 00909
- Site Reference ID/Investigator# 5170
-
San Juan, Puerto Rico, 00918
- Site Reference ID/Investigator# 7509
-
San Juan, Puerto Rico, 00921-3201
- Site Reference ID/Investigator# 6288
-
San Juan, Puerto Rico, 00936-5067
- Site Reference ID/Investigator# 6291
-
Toa Baja, Puerto Rico, 00949
- Site Reference ID/Investigator# 6919
-
Yabucoa, Puerto Rico, 00767
- Site Reference ID/Investigator# 6296
-
-
-
-
-
Barcelona, Spain, 08036
- Site Reference ID/Investigator# 6569
-
Galdakao, Spain, 48960
- Site Reference ID/Investigator# 10621
-
L'Hospitalet de, Spain, 08907
- Site Reference ID/Investigator# 6330
-
Madrid, Spain, 28041
- Site Reference ID/Investigator# 5111
-
Oviedo, Spain, 33006
- Site Reference ID/Investigator# 5110
-
Santander, Spain, 39008
- Site Reference ID/Investigator# 6329
-
Valencia, Spain, 46017
- Site Reference ID/Investigator# 11281
-
-
-
-
-
Hsin-Chuang City, Taiwan
- Site Reference ID/Investigator# 6286
-
Taichung, Taiwan, 433
- Site Reference ID/Investigator# 7927
-
Taichung City, Taiwan, 40764
- Site Reference ID/Investigator# 8335
-
Taipei, Taiwan
- Site Reference ID/Investigator# 6285
-
Taipei City, Taiwan, 10449
- Site Reference ID/Investigator# 6294
-
-
-
-
Arizona
-
Phoenix, Arizona, United States, 85012
- Site Reference ID/Investigator# 862
-
-
California
-
Fountain Valley, California, United States, 92708
- Site Reference ID/Investigator# 864
-
Yuba City, California, United States, 95991
- Site Reference ID/Investigator# 7291
-
-
Florida
-
Hudson, Florida, United States, 34667
- Site Reference ID/Investigator# 853
-
Lauderdale Lakes, Florida, United States, 33313
- Site Reference ID/Investigator# 867
-
Pembroke Pines, Florida, United States, 33028
- Site Reference ID/Investigator# 857
-
West Palm Beach, Florida, United States, 33401
- Site Reference ID/Investigator# 8901
-
-
Georgia
-
Roswell, Georgia, United States, 30076
- Site Reference ID/Investigator# 7113
-
-
Illinois
-
Chicago, Illinois, United States, 60654
- Site Reference ID/Investigator# 2531
-
Evanston, Illinois, United States, 60201
- Site Reference ID/Investigator# 3371
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Site Reference ID/Investigator# 869
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Site Reference ID/Investigator# 8054
-
-
Maryland
-
Rockville, Maryland, United States, 20852
- Site Reference ID/Investigator# 854
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Site Reference ID/Investigator# 6281
-
-
Minnesota
-
Brooklyn Center, Minnesota, United States, 55430
- Site Reference ID/Investigator# 859
-
-
Nebraska
-
Omaha, Nebraska, United States, 68131
- Site Reference ID/Investigator# 7214
-
-
New York
-
Albany, New York, United States, 12206
- Site Reference ID/Investigator# 8046
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28208
- Site Reference ID/Investigator# 866
-
Greenville, North Carolina, United States, 27834
- Site Reference ID/Investigator# 8039
-
Morehead City, North Carolina, United States, 28557
- Site Reference ID/Investigator# 8053
-
Winston-Salem, North Carolina, United States, 27103
- Site Reference ID/Investigator# 6626
-
-
Pennsylvania
-
Carlisle, Pennsylvania, United States, 17015
- Site Reference ID/Investigator# 7495
-
-
Texas
-
Dallas, Texas, United States, 75230
- Site Reference ID/Investigator# 9061
-
Dallas, Texas, United States, 75231
- Site Reference ID/Investigator# 8325
-
Dallas, Texas, United States, 75390
- Site Reference ID/Investigator# 856
-
San Antonio, Texas, United States, 78229
- Site Reference ID/Investigator# 7494
-
San Antonio, Texas, United States, 78229
- Site Reference ID/Investigator# 774
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female participant >= 20 years old.
- Participant has Type 2 Diabetes Mellitus and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the Screening Phase
- Participant has been receiving a stable dose (i.e., same type and regimen) of ACEi and/or ARB for at least three months prior to the Screening Phase. However, participant may have switched to different brands but at equivalent doses during the three months prior to the Screening Phase.
- Participant is not expected to begin dialysis for at least 6 months.
- If female, participant is not breast feeding or is not pregnant.
For entry into the Treatment Phase, the participant must satisfy the following criteria based on the Screening laboratory values:
- Estimated glomerular filtration rate (GFR) between 15-90 mL/min/1.73m2 by simplified Modification in Diet in Renal Disease (MDRD) formula
- Urinary albumin to creatinine ratio (UACR) between 100 and 3000 mg/g as determined by the mean of the three first morning void urine specimens obtained within one week of each other
- Corrected serum calcium level <= 9.8 mg/dL
- intact parathyroid hormone (iPTH) value between 35-500 pg/mL
- Glycosylated hemoglobin A1c (HbA1c) <= 12%
- Serum albumin > 3.0 g/dL
- Negative urine pregnancy test for female participants
Exclusion Criteria:
- Participant has previously been on prescription-based vitamin D therapy within the six months prior to the Screening Phase.
- Participant has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
- Participant has primary glomerulonephritis or secondary nephritis in addition to diabetic nephropathy.
- Participant has had acute renal failure within 12 weeks of the Screening Phase, defined as an acute rise (of >= 0.5 mg/dL) in serum creatinine to > 4 mg/dL.
- Participant has chronic gastrointestinal disease.
- Participant has secondary hypertension.
- Participant has poorly controlled hypertension.
- Participant has a history of kidney stones.
- Participant has a history of drug or alcohol abuse within six months prior to the Screening Phase.
- Participant has evidence of poor compliance with diet or medication.
- Participant has received any investigational drug within 30 days prior to study drug administration.
- Participant 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 participants on stable (same dose and product for three months) estrogen and/or progestin therapy.
- For any reason, participant is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules or is put at risk by study procedures.
- Participant is known to be human immunodeficiency virus (HIV) positive.
- Participant has used known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Paricalcitol 1 mcg
One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
|
Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily)
Other Names:
|
Active Comparator: Paricalcitol 2 mcg
Two paricalcitol 1 mcg capsules per dose
|
Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily)
Other Names:
|
Placebo Comparator: Placebo
Two placebo capsules per dose
|
Group 1 - Placebo once daily (two placebo capsules once daily)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
Time Frame: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.
Time Frame: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment
|
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.
Time Frame: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment
|
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.
Time Frame: Baseline (screening period) through 24 weeks of treatment
|
Change is mean change in picograms of iPTH per milliliter of serum.
|
Baseline (screening period) through 24 weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dennis Andress, MD, Abbott
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Coyne DW, Andress DL, Amdahl MJ, Ritz E, de Zeeuw D. Effects of paricalcitol on calcium and phosphate metabolism and markers of bone health in patients with diabetic nephropathy: results of the VITAL study. Nephrol Dial Transplant. 2013 Sep;28(9):2260-8. doi: 10.1093/ndt/gft227. Epub 2013 Jun 19.
- de Zeeuw D, Agarwal R, Amdahl M, Audhya P, Coyne D, Garimella T, Parving HH, Pritchett Y, Remuzzi G, Ritz E, Andress D. Selective vitamin D receptor activation with paricalcitol for reduction of albuminuria in patients with type 2 diabetes (VITAL study): a randomised controlled trial. Lancet. 2010 Nov 6;376(9752):1543-51. doi: 10.1016/S0140-6736(10)61032-X.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
January 10, 2007
First Submitted That Met QC Criteria
January 11, 2007
First Posted (Estimate)
January 12, 2007
Study Record Updates
Last Update Posted (Estimate)
January 20, 2012
Last Update Submitted That Met QC Criteria
January 18, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Urological Manifestations
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Renal Insufficiency
- Urination Disorders
- Proteinuria
- Kidney Diseases
- Renal Insufficiency, Chronic
- Diabetic Nephropathies
- Albuminuria
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Ergocalciferols
Other Study ID Numbers
- M05-741
- 2006-001363-31 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Nephropathy
-
Zheng GuoNot yet recruitingDiabetic Nephropathy Type 2
-
The Third Xiangya Hospital of Central South UniversityCompletedType 2 Diabetic NephropathyChina
-
Centro Universitario de Ciencias de la Salud, MexicoUnknownDiabetic Nephropathy Type 2Mexico
-
Assiut UniversityUnknownDiabetic Nephropathy Type 2
-
University of Sao Paulo General HospitalCompleted
-
Second Affiliated Hospital, School of Medicine,...Second Affiliated Hospital of Wenzhou Medical University; Lishui Country People...RecruitingDiabetic Nephropathy Type 2 | BiomarkerChina
-
Chinese PLA General HospitalCompletedInsulin Pump Therapy in Treating Diabetic Nephropathy
-
Assiut UniversityNot yet recruitingType 2 DM é Diabetic Nephropathy
-
PfizerTerminatedType 2 Diabetic NephropathyUnited States
-
Chang Gung Memorial HospitalUnknown
Clinical Trials on Zemplar (paricalcitol ) capsules
-
Dr. Reddy's Laboratories LimitedCompleted
-
AbbVie (prior sponsor, Abbott)Massachusetts General HospitalCompletedChronic Kidney Disease | Left Ventricular HypertrophyUnited States, Australia, Czech Republic, Germany, Italy, Poland, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, United Kingdom
-
AbbottCompletedSecondary Hyperparathyroidism | DialysisMexico
-
AbbottCompletedEnd Stage Renal DiseasePoland, United States
-
AbbVie (prior sponsor, Abbott)CompletedChronic Kidney Disease Stage 3 and 4
-
AbbottCompletedChronic Kidney DiseaseChina
-
The University of Hong KongAbbottCompleted
-
AbbottCompletedRenal Insufficiency, Chronic | Hemodialysis | Secondary Hyperparathyroidism | Hypercalcemia | Parathyroid HormonePeru
-
Genzyme, a Sanofi CompanyCompletedSecondary HyperparathyroidismUnited States
-
AbbottAbbott Japan Co.,LtdCompletedHemodialysis | Secondary HyperparathyroidismJapan