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

• ClinicalTrials.gov Identifier: NCT00537979
• Recruitment Status: Completed
• First Posted: October 2, 2007
• Results First Posted: October 25, 2011
• Last Update Posted: October 25, 2011
• Sponsor: Abbott
• Information provided by (Responsible Party): Abbott

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Secondary Hyperparathyroidism; Dialysis	Drug: Paricalcitol injection; Drug: Paricalcitol capsules	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 147 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: September 2007
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

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: ABT-358; paricalcitol; Zemplar
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: ABT-358; paricalcitol; Zemplar

Outcome Measures

Primary Outcome Measures :

1. Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level [ Time Frame: 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 :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

Mexico

Site Ref # / Investigator 19391

Jojutla Morelos, Mexico, CP 62900

Site Ref # / Investigator 19389

Mexico City, Mexico, CP 03900

Site Ref # / Investigator 19390

Mexico City, Mexico, CP 14000

Site Ref # / Investigator 19393

Mexico City, Mexico, CP 14080

Site Ref # / Investigator 19395

Mexico City, Mexico, CP 16070

Site Ref # / Investigator 19392

Mexico D.F., Mexico, CP 01030

Site Ref # / Investigator 19397

Mexico D.F., Mexico, CP 02080

Site Ref # / Investigator 19396

Mexico D.F., Mexico, CP 03650

Site Ref # / Investigator 19394

Mexico D.F., Mexico, CP 14140

Site Ref # / Investigator 19399

Puebla, Mexico, CP 72400

Site Ref # / Investigator 19398

Zapopan, Mexico, CP 45116

Site Ref # / Investigator 19388

Zapopan, Mexico, CP 45150

Sponsors and Collaborators

Abbott

Investigators

• Study Director: Jose-Luis Cañadas, MD; Abbott

More Information

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT00537979
• Other Study ID Numbers: W10-129
• First Posted: October 2, 2007
• Results First Posted: October 25, 2011
• Last Update Posted: October 25, 2011
• Last Verified: September 2011

Keywords provided by Abbott:

Dialysis; Hyperparathyroidism; Zemplar

Additional relevant MeSH terms:

Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary; Neoplastic Processes; Neoplasms; Pathologic Processes; Parathyroid Diseases; Endocrine System Diseases; Ergocalciferols; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vitamins; Micronutrients; Nutrients; Growth Substances; Bone Density Conservation Agents