Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
|ClinicalTrials.gov Identifier: NCT00891813|
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : October 31, 2011
Last Update Posted : October 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|Secondary Hyperparathyroidism Renal Insufficiency, Chronic Parathyroid Hormone Hemodialysis Hypercalcemia||Drug: Zemplar (paricalcitol)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness and Safety of a 6-Month Treatment With IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose|
|Study Start Date :||May 2009|
|Primary Completion Date :||September 2010|
|Study Completion Date :||September 2010|
|Experimental: Zemplar (paracalcitol)||
Drug: Zemplar (paricalcitol)
Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.
- The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL [ Time Frame: 24 weeks ]The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.
- Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL [ Time Frame: 24 Weeks ]Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL.
- Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65). [ Time Frame: 24 Weeks ]The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter [mg/dL]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891813
|Site Reference ID/Investigator# 21401|
|Callao, Peru, CALLAO 2|
|Site Reference ID/Investigator# 23857|
|Lima, Peru, Lima-11|
|Site Reference ID/Investigator# 10941|
|Study Director:||Oscar E Guerra, MD||Abbott|