Spots Global Cancer Trial Database for Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
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Trial Identification
Brief Title: Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Official Title: The IMPACT SHPT Study: Study to Evaluate the Improved Management of iPTH With Paricalcitol-centered Therapy vs. Cinacalcet Therapy With Low-dose Vitamin D in Hemodialysis Patients With Secondary Hyperparathyroidism
Study ID: NCT00977080
Study Description
Brief Summary: Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
Detailed Description: During a 4-week washout period, participants stopped taking cinacalcet or other vitamin D receptor activators (VDRAs). (Participants who were naive to cinacalcet or VDRAs did not have to wash out). At randomization, participants entered a 28-week open-label treatment period, during which they received either cinacalcet or paricalcitol. Participants who were assigned to receive paricalcitol were dosed according to the approved label in their respective geographic regions (i.e., IV at sites in the US and Russia and oral at sites in Europe). Supplemental cinacalcet was administered to participants in the paricalcitol arms who developed hypercalcemia (defined as \>= 10.5 mg/dL). The evaluation period was from Weeks 21 to 28.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site Reference ID/Investigator# 22781, Tempe, Arizona, United States
Site Reference ID/Investigator# 24342, Chula Vista, California, United States
Site Reference ID/Investigator# 21142, Los Angeles, California, United States
Site Reference ID/Investigator# 22762, Los Angeles, California, United States
Site Reference ID/Investigator# 22758, Riverside, California, United States
Site Reference ID/Investigator# 21442, San Diego, California, United States
Site Reference ID/Investigator# 23688, Arvada, Colorado, United States
Site Reference ID/Investigator# 21370, Coral Springs, Florida, United States
Site Reference ID/Investigator# 25902, Hudson, Florida, United States
Site Reference ID/Investigator# 21146, Lauderdale Lakes, Florida, United States
Site Reference ID/Investigator# 26743, Lauderdale Lakes, Florida, United States
Site Reference ID/Investigator# 22788, Miami, Florida, United States
Site Reference ID/Investigator# 22722, Orlando, Florida, United States
Site Reference ID/Investigator# 23147, Tampa, Florida, United States
Site Reference ID/Investigator# 22778, Meridian, Idaho, United States
Site Reference ID/Investigator# 21369, Detroit, Michigan, United States
Site Reference ID/Investigator# 22786, Detroit, Michigan, United States
Site Reference ID/Investigator# 21144, St. Louis, Missouri, United States
Site Reference ID/Investigator# 21443, St. Louis, Missouri, United States
Site Reference ID/Investigator# 21145, Omaha, Nebraska, United States
Site Reference ID/Investigator# 22505, Flushing, New York, United States
Site Reference ID/Investigator# 22759, Toledo, Ohio, United States
Site Reference ID/Investigator# 22796, Lancaster, Pennsylvania, United States
Site Reference ID/Investigator# 22770, Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 22772, Aiken, South Carolina, United States
Site Reference ID/Investigator# 21147, Orangeburg, South Carolina, United States
Site Reference ID/Investigator# 22982, Houston, Texas, United States
Site Reference ID/Investigator# 21143, Houston, Texas, United States
Site Reference ID/Investigator# 22506, San Antonio, Texas, United States
Site Reference ID/Investigator# 22776, Bluefield, West Virginia, United States
Site Reference ID/Investigator# 22311, Brno, , Czech Republic
Site Reference ID/Investigator# 22310, Jilemnice, , Czech Republic
Site Reference ID/Investigator# 21624, Usti nad Labem, , Czech Republic
Site Reference ID/Investigator# 22363, Aalborg, , Denmark
Site Reference ID/Investigator# 23105, Copenhagen, , Denmark
Site Reference ID/Investigator# 23909, Fredericia, , Denmark
Site Reference ID/Investigator# 22462, Holstebro, , Denmark
Site Reference ID/Investigator# 21748, Coburg, , Germany
Site Reference ID/Investigator# 33268, Darmstadt, , Germany
Site Reference ID/Investigator# 35903, Duesseldorf, , Germany
Site Reference ID/Investigator# 21742, Frankfurt, , Germany
Site Reference ID/Investigator# 21744, Heilbronn, , Germany
Site Reference ID/Investigator# 21368, Luedenscheid, , Germany
Site Reference ID/Investigator# 22362, Athens, , Greece
Site Reference ID/Investigator# 38970, Thessaloniki, , Greece
Site Reference ID/Investigator# 22322, Thessaloniki, , Greece
Site Reference ID/Investigator# 22463, Thessaloniki, , Greece
Site Reference ID/Investigator# 22323, Thessaloniki, , Greece
Site Reference ID/Investigator# 39262, Thessaloniki, , Greece
Site Reference ID/Investigator# 22312, Bergamo, , Italy
Site Reference ID/Investigator# 21746, Genova, , Italy
Site Reference ID/Investigator# 39180, Lucca, , Italy
Site Reference ID/Investigator# 22314, Milan, , Italy
Site Reference ID/Investigator# 21367, Pavia, , Italy
Site Reference ID/Investigator# 21745, Pesaro, , Italy
Site Reference ID/Investigator# 21842, Alkmaar, , Netherlands
Site Reference ID/Investigator# 22309, Delft, , Netherlands
Site Reference ID/Investigator# 21843, Dordrecht, , Netherlands
Site Reference ID/Investigator# 38903, Beja, , Portugal
Site Reference ID/Investigator# 38531, Faro, , Portugal
Site Reference ID/Investigator# 22464, Lisbon, , Portugal
Site Reference ID/Investigator# 23910, Vila Franca de Xira, , Portugal
Site Reference ID/Investigator# 24643, Moscow, , Russian Federation
Site Reference ID/Investigator# 24642, Moscow, , Russian Federation
Site Reference ID/Investigator# 21361, Barcelona, , Spain
Site Reference ID/Investigator# 21364, Cordoba, , Spain
Site Reference ID/Investigator# 22366, L'Hospitalet, Barcelona, , Spain
Site Reference ID/Investigator# 38343, Madrid, , Spain
Site Reference ID/Investigator# 21362, Madrid, , Spain
Site Reference ID/Investigator# 21363, Palma de Mallorca, , Spain
Site Reference ID/Investigator# 22367, Pamplona, , Spain
Site Reference ID/Investigator# 38462, Puerto de la Cruz, , Spain
Site Reference ID/Investigator# 21365, Seville, , Spain
Site Reference ID/Investigator# 23913, Linkoping, , Sweden
Site Reference ID/Investigator# 23782, Stockholm, , Sweden
Site Reference ID/Investigator# 22364, Uppsala, , Sweden
Site Reference ID/Investigator# 23912, Birmingham, , United Kingdom
Site Reference ID/Investigator# 21747, Coventry, , United Kingdom
Site Reference ID/Investigator# 23102, London, , United Kingdom
Site Reference ID/Investigator# 23104, London, , United Kingdom
Site Reference ID/Investigator# 23103, Manchester, , United Kingdom
Site Reference ID/Investigator# 41982, Omagh, Northern Ireland, , United Kingdom
Site Reference ID/Investigator# 40222, Sheffield, , United Kingdom
Contact Details
Name: Samina Khan, MD
Affiliation: Abbott
Role: STUDY_DIRECTOR
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