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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
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
November 1, 2009
Primary Completion Date
May 1, 2011
Completion Date
May 1, 2011
Last Updated
June 20, 2012
272
ACTUAL participants
Paricalcitol
DRUG
Cinacalcet
DRUG
Lead Sponsor
Abbott
NCT07241390
NCT06926660
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06717698