Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
This study has been completed.
Sponsor:
Abbott
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00537979
First received: September 28, 2007
Last updated: September 16, 2011
Last verified: September 2011
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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 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:
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 ]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 ]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 ]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 ]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 ]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 ]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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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
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 |
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 May 25, 2017