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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Ergocalciferols

Criteria

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