Clinical trial NCT00891813: Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
Renal Insufficiency, Chronic
Parathyroid Hormone
Hemodialysis
Hypercalcemia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients \>=18 years old with secondary hyperparathyroidism (PTH\>300pg/mL, measured in the last 2 weeks).
* Patients on hemodialysis who require starting therapy with IV paricalcitol (de novo).
* Patients attending 3 hemodialysis sessions per week.
* Patients signing the informed consent approved by the Ethics Committee. If any individual is not capable of giving his/her consent, it can be obtained from a next of kin or from his/her legal representative, according to local laws and regulations.
* The decision to initiate treatment is upon the investigator and the decision to treat patients with IV paricalcitol must not be based on the inclusion of the patient in the study or any other way. The decision to treat a patient with IV paricalcitol will be taken prior to asking the patient to participate in the study.

Exclusion Criteria:

* Patients with any concomitant clinical condition that, according to the investigator's opinion, might impede an adequate assessment of the treatment response.
* Patients with severe hyperparathyroidism (PTH\>3000pg/mL).
* Patients with a serum calcium level greater or equal to 10.5mg/dL, phosphorus greater or equal to 6.5mg/dL, or those with Calcium X Phosphorus product 65 (measured at least 2 weeks before the study).
* Patients with neoplastic disease.
* Pregnant or lactating women.
* Known hypersensitivity and/or toxicity to vitamin D metabolites and/or to other ingredients of the product.
* Having participated in another study with an investigational product or device within the previous 30 days or having planned to participate in another study within the same period of time as the actual study.
* Use of vitamin D analogue during the last 3 months prior to the inclusion to this study.

Primary outcomes:
measure: The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL
timeFrame: 24 weeks
Secondary outcomes:
measure: Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL
timeFrame: 24 Weeks
measure: Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Callao
country: Peru
facility: Site Reference ID/Investigator# 21401
city: Lima
country: Peru
facility: Site Reference ID/Investigator# 23857
city: Lima
country: Peru
facility: Site Reference ID/Investigator# 10941
Study officials:
affiliation: Abbott
name: Oscar E Guerra, MD
role: STUDY_DIRECTOR
References: