Status:
COMPLETED
Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
Lead Sponsor:
Abbott
Conditions:
Secondary Hyperparathyroidism
Renal Insufficiency, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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\>300p...
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 Base...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00891813
Start Date
May 1 2009
End Date
September 1 2010
Last Update
October 31 2011
Active Locations (3)
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1
Site Reference ID/Investigator# 21401
Callao, Peru, CALLAO 2
2
Site Reference ID/Investigator# 23857
Lima, Peru, Lima-11
3
Site Reference ID/Investigator# 10941
Lima, Peru