Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)
This study has been completed.
Sponsor:
Abbott
Collaborator:
Abbott Japan Co.,Ltd
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00701805
First received: June 17, 2008
Last updated: March 18, 2011
Last verified: March 2011
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Purpose
The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).
| Condition | Intervention | Phase |
|---|---|---|
|
Secondary Hyperparathyroidism Hemodialysis |
Drug: Paricalcitol |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- The Percentage of Participants With of Hypercalcemia [ Time Frame: Anytime during the study through Week 53 ] [ Designated as safety issue: Yes ]The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study.
- The Percentage of Participants With Hyperphosphatemia [ Time Frame: Anytime during the study through Week 53 ] [ Designated as safety issue: Yes ]The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study.
Secondary Outcome Measures:
- The Mean Change in Intact Parathyroid Hormone (iPTH) [ Time Frame: From Baseline to Final Visit (which could occur anytime between study initiation and Week 53) ] [ Designated as safety issue: No ]
- The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit [ Time Frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) ] [ Designated as safety issue: No ]
- The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50% [ Time Frame: Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53) ] [ Designated as safety issue: No ]
- Change in Mean iPTH [ Time Frame: Every week from Baseline through Week 13 and every other week thereafter until Week 53 ] [ Designated as safety issue: No ]
- Duration of 2 Consecutive Decreases in iPTH >= 50% [ Time Frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) ] [ Designated as safety issue: No ]
- Duration of 2 Consecutive iPTH Values <= 180 pg/mL [ Time Frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53) ] [ Designated as safety issue: No ]
- The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit [ Time Frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) ] [ Designated as safety issue: No ]
- The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit [ Time Frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) ] [ Designated as safety issue: No ]
| Enrollment: | 107 |
| Study Start Date: | July 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paricalcitol 2 µg ± 1 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
|
Drug: Paricalcitol
Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.
Other Names:
|
|
Experimental: Paricalcitol 2 µg ± 2 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
|
Drug: Paricalcitol
Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.
Other Names:
|
|
Experimental: Paricalcitol 4 µg ± 1 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
|
Drug: Paricalcitol
Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.
Other Names:
|
|
Experimental: Paricalcitol 4 µg ± 2 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
|
Drug: Paricalcitol
Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.
Other Names:
|
Detailed Description:
The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who completed 12 weeks of Study M10-309 (NCT00667576).
Exclusion Criteria:
- Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone metabolism.
- Patients with progressive malignancy or clinically significant hepatic disease.
- Patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
- Patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701805
Locations
| Japan | |
| Aichi, Japan | |
| Chiba, Japan | |
| Fukuoka, Japan | |
| Hokkaido, Japan | |
| Ibaragi, Japan | |
| Kanagawa, Japan | |
| Kumamoto, Japan | |
| Nagano, Japan | |
| Nagasaki, Japan | |
| Osaka, Japan | |
| Saitama, Japan | |
| Tokyo, Japan | |
Sponsors and Collaborators
Abbott
Abbott Japan Co.,Ltd
Investigators
| Study Director: | Moriaki KUBO | Abbott |
More Information
Additional Information:
No publications provided
| Responsible Party: | Yoshihiko Ueki, Abbott |
| ClinicalTrials.gov Identifier: | NCT00701805 History of Changes |
| Other Study ID Numbers: | M10-312 |
| Study First Received: | June 17, 2008 |
| Results First Received: | December 28, 2010 |
| Last Updated: | March 18, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Abbott:
|
Secondary hyperparathyroidism Hemodialysis paricalcitol |
Additional relevant MeSH terms:
|
Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Parathyroid Diseases Endocrine System Diseases Urologic Diseases |
Renal Insufficiency Ergocalciferols Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013