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

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537979
• Other study ID #: W10-129
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2007
• Last updated: September 16, 2011
• Start date: September 2007
• Est. completion date: July 2010

Study information

• Verified date: September 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dialysis
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

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
• 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

Locations

Country	Name	City	State
Mexico	Site Ref # / Investigator 19391	Jojutla Morelos
Mexico	Site Ref # / Investigator 19389	Mexico City
Mexico	Site Ref # / Investigator 19390	Mexico City
Mexico	Site Ref # / Investigator 19393	Mexico City
Mexico	Site Ref # / Investigator 19395	Mexico City
Mexico	Site Ref # / Investigator 19392	Mexico D.F.
Mexico	Site Ref # / Investigator 19394	Mexico D.F.
Mexico	Site Ref # / Investigator 19396	Mexico D.F.
Mexico	Site Ref # / Investigator 19397	Mexico D.F.
Mexico	Site Ref # / Investigator 19399	Puebla
Mexico	Site Ref # / Investigator 19388	Zapopan
Mexico	Site Ref # / Investigator 19398	Zapopan

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
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	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	No
Secondary	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	No
Secondary	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	No