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

Purpose

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	Intervention	Phase
Secondary Hyperparathyroidism Dialysis	Drug: Paricalcitol injection Drug: Paricalcitol capsules	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Paricalcitol

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
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.


Enrollment:	147
Study Start Date:	September 2007
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537979

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 History of Changes
Other Study ID Numbers:	W10-129
Study First Received:	September 28, 2007
Results First Received:	July 20, 2011
Last Updated:	September 16, 2011
Health Authority:	Mexico: Ministry of Health

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 Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 23, 2016