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Clinical Trial Details

Trial ID: L1524
Source ID: NCT01084538
Associated Drug: Zemplar Iv (Paricalcitol Iv)
Title: Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01084538/results
Conditions: Parathyroid Hormone
Interventions: DRUG: Zemplar iv (paricalcitol iv)
Outcome Measures: Primary: Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline, Baseline through 12 months | Secondary: Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL), Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit., Baseline through 12 months|Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL, The average time (measured in days) to achieve target iPTH levels., Baseline through 12 months|Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements., Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study., Baseline through 12 months
Sponsor/Collaborators: Sponsor: Abbott
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 181
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2007-09
Completion Date: 2010-06
Results First Posted: 2011-09-12
Last Update Posted: 2011-09-21
Locations: Site Reference ID/Investigator# 27525, Dubrovnik, 20000, Croatia|Site Reference ID/Investigator# 27531, Imotski, 21260, Croatia|Site Reference ID/Investigator# 6175, Karlovac, 47000, Croatia|Site Reference ID/Investigator# 27528, Pula, 52100, Croatia|Site Reference ID/Investigator# 27533, Rijeka, 51000, Croatia|Site Reference ID/Investigator# 27524, Sibenik, 22000, Croatia|Site Reference ID/Investigator# 27523, Sisak, 44000, Croatia|Site Reference ID/Investigator# 27529, Slavonski Brod, 35000, Croatia|Site Reference ID/Investigator# 27530, Split, 1000, Croatia|Site Reference ID/Investigator# 27534, Trogir, 21220, Croatia|Site Reference ID/Investigator# 27522, Vinkovci, 32000, Croatia|Site Reference ID/Investigator# 27527, Zadar, 23000, Croatia|Site Reference ID/Investigator# 27526, Zagreb, 10000, Croatia|Site Reference ID/Investigator# 27532, Zagreb, 10000, Croatia|Site Reference ID/Investigator# 27536, Beograd, 11000, Serbia|Site Reference ID/Investigator# 27538, Beograd, 11000, Serbia|Site Reference ID/Investigator# 27539, Beograd, 11000, Serbia|Site Reference ID/Investigator# 6169, Beograd, 11000, Serbia|Site Reference ID/Investigator# 27540, Beograd, 11080, Serbia|Site Reference ID/Investigator# 27535, Bor, 19210, Serbia|Site Reference ID/Investigator# 27537, Kragujevac, 34000, Serbia
URL: https://clinicaltrials.gov/show/NCT01084538