Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose

Abbott

Status and phase

Completed

Phase 4

Conditions

Parathyroid Hormone

Hemodialysis

Hypercalcemia

Secondary Hyperparathyroidism

Renal Insufficiency, Chronic

Treatments

Drug: Zemplar (paricalcitol)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00891813

W10-677

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.