Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis

Abbott

Status and phase

Completed

Phase 4

Conditions

Dialysis

Secondary Hyperparathyroidism

Treatments

Drug: Paricalcitol capsules

Drug: Paricalcitol injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00537979

W10-129

Details and patient eligibility

About

Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis.

Enrollment

147 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients >=18 years with secondary hyperparathyroidism (iPTH >= 300 pg/mL)
Patients in a chronic hemodialysis or peritoneal dialysis program previously treated with vitamin D metabolites or without previous treatment
Patients in which treatment with paricalcitol injection or oral is clinically indicated according to the criteria of the participating investigator
Patients providing their signed informed consent to participate in the trial

Exclusion criteria

Patients with severe hyperparathyroidism (iPTH > 3,000 pg/ml)
Patients with hypercalcaemia (calcium >=11.0 mg/dl, adjusted according to Albumin level), hyperphosphataemia (phosphorus >= 6.5 mg/dl) or patients with calcium x phosphorus >= 70
Known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients
Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies
Patients who cannot tolerate or take phosphorus binders that do not contain Calcium and/or Aluminum
Patients that in the opinion of the investigator, for any reason, are not good candidates for therapy with Synthetic Analogues of Vitamin D