The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors
NCT ID: NCT00421733
Last Updated: 2012-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
281 participants
INTERVENTIONAL
2006-12-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Paricalcitol 1 mcg
One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
Zemplar (paricalcitol ) capsules
Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily)
Paricalcitol 2 mcg
Two paricalcitol 1 mcg capsules per dose
Zemplar (paricalcitol) capsules
Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily)
Placebo
Two placebo capsules per dose
Placebo
Group 1 - Placebo once daily (two placebo capsules once daily)
Interventions
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Zemplar (paricalcitol ) capsules
Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily)
Zemplar (paricalcitol) capsules
Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily)
Placebo
Group 1 - Placebo once daily (two placebo capsules once daily)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis Andress, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator# 862
Phoenix, Arizona, United States
Site Reference ID/Investigator# 864
Fountain Valley, California, United States
Site Reference ID/Investigator# 7291
Yuba City, California, United States
Site Reference ID/Investigator# 853
Hudson, Florida, United States
Site Reference ID/Investigator# 867
Lauderdale Lakes, Florida, United States
Site Reference ID/Investigator# 857
Pembroke Pines, Florida, United States
Site Reference ID/Investigator# 8901
West Palm Beach, Florida, United States
Site Reference ID/Investigator# 7113
Roswell, Georgia, United States
Site Reference ID/Investigator# 2531
Chicago, Illinois, United States
Site Reference ID/Investigator# 3371
Evanston, Illinois, United States
Site Reference ID/Investigator# 869
Indianapolis, Indiana, United States
Site Reference ID/Investigator# 8054
Baton Rouge, Louisiana, United States
Site Reference ID/Investigator# 854
Rockville, Maryland, United States
Site Reference ID/Investigator# 6281
Boston, Massachusetts, United States
Site Reference ID/Investigator# 859
Brooklyn Center, Minnesota, United States
Site Reference ID/Investigator# 7214
Omaha, Nebraska, United States
Site Reference ID/Investigator# 8046
Albany, New York, United States
Site Reference ID/Investigator# 866
Charlotte, North Carolina, United States
Site Reference ID/Investigator# 8039
Greenville, North Carolina, United States
Site Reference ID/Investigator# 8053
Morehead City, North Carolina, United States
Site Reference ID/Investigator# 6626
Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 7495
Carlisle, Pennsylvania, United States
Site Reference ID/Investigator# 9061
Dallas, Texas, United States
Site Reference ID/Investigator# 8325
Dallas, Texas, United States
Site Reference ID/Investigator# 856
Dallas, Texas, United States
Site Reference ID/Investigator# 7494
San Antonio, Texas, United States
Site Reference ID/Investigator# 774
San Antonio, Texas, United States
Site Reference ID/Investigator# 6316
Düsseldorf, , Germany
Site Reference ID/Investigator# 5167
Hanover, , Germany
Site Reference ID/Investigator# 6302
Ludwigshafen, , Germany
Site Reference ID/Investigator# 6314
Athens, , Greece
Site Reference ID/Investigator# 6306
Ioannina, , Greece
Site Reference ID/Investigator# 5631
Thessaloniki, , Greece
Site Reference ID/Investigator# 6310
Thessaloniki, , Greece
Site Reference ID/Investigator# 6312
Bergamo, , Italy
Site Reference ID/Investigator# 6303
Brescia, , Italy
Site Reference ID/Investigator# 6309
Milan, , Italy
Site Reference ID/Investigator# 6210
Modena, , Italy
Site Reference ID/Investigator# 6207
Groningen, , Netherlands
Site Reference ID/Investigator# 6304
Bydgoszcz, , Poland
Site Reference ID/Investigator# 5622
Katowice, , Poland
Site Reference ID/Investigator# 5203
Szczecin, , Poland
Site Reference ID/Investigator# 6315
Warsaw, , Poland
Site Reference ID/Investigator# 6327
Lisbon, , Portugal
Site Reference ID/Investigator# 6326
Porto, , Portugal
Site Reference ID/Investigator# 6916
Caguas, , Puerto Rico
Site Reference ID/Investigator# 5175
Carolina, , Puerto Rico
Site Reference ID/Investigator# 6290
Las Piedras, , Puerto Rico
Site Reference ID/Investigator# 5179
Ponce, , Puerto Rico
Site Reference ID/Investigator# 6293
Ponce, , Puerto Rico
Site Reference ID/Investigator# 5173
Ponce, , Puerto Rico
Site Reference ID/Investigator# 6300
Ponce, , Puerto Rico
Site Reference ID/Investigator# 5168
Ponce, , Puerto Rico
Site Reference ID/Investigator# 7298
Rio Piedras, , Puerto Rico
Site Reference ID/Investigator# 5170
San Juan, , Puerto Rico
Site Reference ID/Investigator# 7509
San Juan, , Puerto Rico
Site Reference ID/Investigator# 6288
San Juan, , Puerto Rico
Site Reference ID/Investigator# 6291
San Juan, , Puerto Rico
Site Reference ID/Investigator# 6919
Toa Baja, , Puerto Rico
Site Reference ID/Investigator# 6296
Yabucoa, , Puerto Rico
Site Reference ID/Investigator# 6569
Barcelona, , Spain
Site Reference ID/Investigator# 10621
Galdakao, , Spain
Site Reference ID/Investigator# 6330
L'Hospitalet de, , Spain
Site Reference ID/Investigator# 5111
Madrid, , Spain
Site Reference ID/Investigator# 5110
Oviedo, , Spain
Site Reference ID/Investigator# 6329
Santander, , Spain
Site Reference ID/Investigator# 11281
Valencia, , Spain
Site Reference ID/Investigator# 8335
Taichung, , Taiwan
Site Reference ID/Investigator# 7927
Taichung, , Taiwan
Site Reference ID/Investigator# 6294
Taipei, , Taiwan
Site Reference ID/Investigator# 6285
Taipei, , Taiwan
Site Reference ID/Investigator# 6286
Xinzhuang, , Taiwan
Countries
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References
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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.
Other Identifiers
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2006-001363-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M05-741
Identifier Type: -
Identifier Source: org_study_id
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