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

Phase 4

Completed

Conditions: Secondary Hyperparathyroidism
Dialysis

Interventions: Drug: Paricalcitol capsules
Drug: Paricalcitol injection

Registration Number: NCT00537979

Lead Sponsor: Abbott

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 147

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paricalcitol capsules	Paricalcitol capsules	ABT-358 Zemplar
Paricalcitol injection	Paricalcitol injection	ABT-358 Zemplar

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)	24 Weeks	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.
Proportion of Subjects Who Achieve an iPTH <300 pg/mL	24 weeks	Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL.
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	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%.
Duration of Response to Treatment	24 weeks	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.
Health-related Quality of Life With Paricalcitol Injection or Oral Treatment	Baseline and 24 weeks	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.

Trial Locations

Locations (12): Site Ref # / Investigator 19391
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Jojutla Morelos, Mexico
Site Ref # / Investigator 19389
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Mexico City, Mexico
Site Ref # / Investigator 19396
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Mexico D.F., Mexico
Site Ref # / Investigator 19399
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Puebla, Mexico
Site Ref # / Investigator 19398
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Zapopan, Mexico
Site Ref # / Investigator 19390
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Mexico City, Mexico
Site Ref # / Investigator 19393
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Mexico City, Mexico
Site Ref # / Investigator 19397
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Mexico D.F., Mexico
Site Ref # / Investigator 19388
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Zapopan, Mexico
Site Ref # / Investigator 19392
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Mexico D.F., Mexico
Site Ref # / Investigator 19394
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Mexico D.F., Mexico
Site Ref # / Investigator 19395
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Mexico City, Mexico