The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH\>300pg/mL) and that require dialysis at least 3 times per week.
The study will be carried out in three dialysis centers in Peru. Each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. Study visits will occur at Baseline and at Weeks 4, 8, 12 and 24 during the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Site Reference ID/Investigator# 21401
Callao, Peru
Site Reference ID/Investigator# 23857
Lima, Peru
Site Reference ID/Investigator# 10941
Lima, Peru
The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL
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 frame: 24 weeks
Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL
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.
Time frame: 24 Weeks
Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).
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.
Time frame: 24 Weeks
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