Prospective, Non-randomized, Multicenter Study to Assess the Efficacy and Safety of Oral or Intravenous Paricalcitol Administered Over 6 Months to Patients With Secondary Hyperparathyroidism on Dialysis

Abbott12 sites in 1 country147 target enrollmentSeptember 2007

ConditionsSecondary Hyperparathyroidism Dialysis

InterventionsParicalcitol injection Paricalcitol capsules

DrugsParicalcitol injection Paricalcitol capsules

Overview

Phase: Phase 4
Intervention: Paricalcitol injection
Conditions: Secondary Hyperparathyroidism
Sponsor: Abbott
Enrollment: 147
Locations: 12
Primary Endpoint: Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

July 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Paricalcitol injection

ABT-358 Zemplar

Intervention: Paricalcitol injection

Paricalcitol capsules

ABT-358 Zemplar

Intervention: Paricalcitol capsules

Outcomes

Primary Outcomes

Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level

Time Frame: 24 weeks

Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.

Secondary Outcomes

Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)(24 Weeks)
Proportion of Subjects Who Achieve an iPTH <300 pg/mL(24 weeks)
Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level(24 weeks)
Duration of Response to Treatment(24 weeks)
Health-related Quality of Life With Paricalcitol Injection or Oral Treatment(Baseline and 24 weeks)