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

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

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.

Study Overview

• Status: Completed
• Conditions: Secondary Hyperparathyroidism; Dialysis
• Intervention / Treatment: Drug: Paricalcitol injection; Drug: Paricalcitol capsules

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Jojutla Morelos, Mexico, CP 62900
    • Site Ref # / Investigator 19391
  • Mexico City, Mexico, CP 03900
    • Site Ref # / Investigator 19389
  • Mexico City, Mexico, CP 14000
    • Site Ref # / Investigator 19390
  • Mexico City, Mexico, CP 14080
    • Site Ref # / Investigator 19393
  • Mexico City, Mexico, CP 16070
    • Site Ref # / Investigator 19395
  • Mexico D.F., Mexico, CP 01030
    • Site Ref # / Investigator 19392
  • Mexico D.F., Mexico, CP 02080
    • Site Ref # / Investigator 19397
  • Mexico D.F., Mexico, CP 03650
    • Site Ref # / Investigator 19396
  • Mexico D.F., Mexico, CP 14140
    • Site Ref # / Investigator 19394
  • Puebla, Mexico, CP 72400
    • Site Ref # / Investigator 19399
  • Zapopan, Mexico, CP 45116
    • Site Ref # / Investigator 19398
  • Zapopan, Mexico, CP 45150
    • Site Ref # / Investigator 19388

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Jose-Luis Cañadas, MD, Abbott

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: September 28, 2007
• First Submitted That Met QC Criteria: September 28, 2007
• First Posted (Estimate): October 2, 2007

Study Record Updates

• Last Update Posted (Estimate): October 25, 2011
• Last Update Submitted That Met QC Criteria: September 16, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Dialysis; Hyperparathyroidism; Zemplar
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Neoplastic Processes; Hyperparathyroidism; Neoplasm Metastasis; Hyperparathyroidism, Secondary; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Ergocalciferols
• Other Study ID Numbers: W10-129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No