Phase 4
N=147
Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
Secondary Hyperparathyroidism · Dialysis
Bottom Line
View on ClinicalTrials.gov: NCT00537979 ↗Enrolled (actual)
147
Serious AEs
11.6%
Results posted
Oct 2011
Primary outcome: Primary: Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level — 17; 57 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paricalcitol injection (Drug); Paricalcitol capsules (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level |
17; 57 | — |
| SECONDARY Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75) |
2; 6; 9; 19; 3; 14 | — |
| SECONDARY Proportion of Subjects Who Achieve an iPTH <300 pg/mL |
16; 57 | — |
| SECONDARY 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 |
43.80; 48.68; 40.29 | — |
| SECONDARY Duration of Response to Treatment |
65.86 | — |
| SECONDARY Health-related Quality of Life With Paricalcitol Injection or Oral Treatment |
13; 38; 19; 47; 0; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00537979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.