Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
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ClinicalTrials.gov Identifier: NCT00537979 |
Recruitment Status :
Completed
First Posted : October 2, 2007
Results First Posted : October 25, 2011
Last Update Posted : October 25, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Secondary Hyperparathyroidism Dialysis | Drug: Paricalcitol injection Drug: Paricalcitol capsules | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Paricalcitol injection
ABT-358 Zemplar
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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:
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Active Comparator: Paricalcitol capsules
ABT-358 Zemplar
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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:
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- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537979
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 |
Study Director: | Jose-Luis Cañadas, MD | Abbott |
Responsible Party: | Abbott |
ClinicalTrials.gov Identifier: | NCT00537979 |
Other Study ID Numbers: |
W10-129 |
First Posted: | October 2, 2007 Key Record Dates |
Results First Posted: | October 25, 2011 |
Last Update Posted: | October 25, 2011 |
Last Verified: | September 2011 |
Dialysis Hyperparathyroidism Zemplar |
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 |