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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Secondary Hyperparathyroidism, Dialysis

Intervention / Treatment
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* Drug: Paricalcitol injection
* Drug: Paricalcitol capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paricalcitol injection<br>ABT-358 Zemplar | Drug: Paricalcitol injection<br>* Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly<br>* Other names: Zemplar;|
| Active Comparator: Paricalcitol capsules<br>ABT-358 Zemplar | Drug: Paricalcitol capsules<br>* Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly<br>* Other names: Zemplar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level | Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75) | Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75. | 24 Weeks | 
| Proportion of Subjects Who Achieve an iPTH <300 pg/mL | Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 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 | Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%. | 24 weeks | 
| Duration of Response to Treatment | Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit. | 24 weeks | 
| Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules. | Baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Hyperparathyroidism, Zemplar