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Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

Primary Purpose

Secondary Hyperparathyroidism, Hemodialysis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
paricalcitol
maxacalcitol
paricalcitol placebo
maxacalcitol placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Secondary hyperparathyroidism, Paricalcitol, Hemodialysis, Maxacalcitol

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders
  • On three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus (P) less than or equal to 6.5 mg/dL.

Exclusion Criteria:

  • Patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes
  • Patients who have received a parathyroidectomy or ethanol infusion within the prior year
  • Patients taking drugs that affect iPTH, calcium or bone metabolism
  • Patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
  • Female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.

Sites / Locations

  • Site Reference ID/Investigator# 53485
  • Site Reference ID/Investigator# 51571
  • Site Reference ID/Investigator# 52963
  • Site Reference ID/Investigator# 52966
  • Site Reference ID/Investigator# 51578
  • Site Reference ID/Investigator# 52965
  • Site Reference ID/Investigator# 53782
  • Site Reference ID/Investigator# 57483
  • Site Reference ID/Investigator# 57487
  • Site Reference ID/Investigator# 53484
  • Site Reference ID/Investigator# 54385
  • Site Reference ID/Investigator# 51581
  • Site Reference ID/Investigator# 59164
  • Site Reference ID/Investigator# 51574
  • Site Reference ID/Investigator# 51575
  • Site Reference ID/Investigator# 52751
  • Site Reference ID/Investigator# 62025
  • Site Reference ID/Investigator# 54384
  • Site Reference ID/Investigator# 52745
  • Site Reference ID/Investigator# 51569
  • Site Reference ID/Investigator# 52964
  • Site Reference ID/Investigator# 53483
  • Site Reference ID/Investigator# 51582
  • Site Reference ID/Investigator# 54388
  • Site Reference ID/Investigator# 51576
  • Site Reference ID/Investigator# 51577
  • Site Reference ID/Investigator# 51580
  • Site Reference ID/Investigator# 52747
  • Site Reference ID/Investigator# 52748
  • Site Reference ID/Investigator# 52750
  • Site Reference ID/Investigator# 51570
  • Site Reference ID/Investigator# 54387
  • Site Reference ID/Investigator# 52746
  • Site Reference ID/Investigator# 51579
  • Site Reference ID/Investigator# 62024
  • Site Reference ID/Investigator# 51572
  • Site Reference ID/Investigator# 52752
  • Site Reference ID/Investigator# 53482
  • Site Reference ID/Investigator# 59162
  • Site Reference ID/Investigator# 59966
  • Site Reference ID/Investigator# 53783
  • Site Reference ID/Investigator# 54383
  • Site Reference ID/Investigator# 52749
  • Site Reference ID/Investigator# 52962
  • Site Reference ID/Investigator# 59163

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paricalcitol

Maxacalcitol

Arm Description

Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.

Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.

Outcomes

Primary Outcome Measures

Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia
The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.

Secondary Outcome Measures

Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia
The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.
Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)
The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
iPTH control was defined as a ≥ 50% reduction from baseline. iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory.
Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL
iPTH control was defined as being within the target range of 60 to 180 pg/mL. iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory.

Full Information

First Posted
April 25, 2011
Last Updated
April 17, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT01341782
Brief Title
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Official Title
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Hemodialysis
Keywords
Secondary hyperparathyroidism, Paricalcitol, Hemodialysis, Maxacalcitol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol
Arm Type
Experimental
Arm Description
Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
Arm Title
Maxacalcitol
Arm Type
Active Comparator
Arm Description
Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
Intervention Type
Drug
Intervention Name(s)
paricalcitol
Other Intervention Name(s)
ABT-358, Zemplar
Intervention Type
Drug
Intervention Name(s)
maxacalcitol
Other Intervention Name(s)
oxarol
Intervention Type
Drug
Intervention Name(s)
paricalcitol placebo
Intervention Type
Drug
Intervention Name(s)
maxacalcitol placebo
Primary Outcome Measure Information:
Title
Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia
Description
The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
Time Frame
iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).
Secondary Outcome Measure Information:
Title
Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia
Description
The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.
Time Frame
Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).
Title
Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)
Description
The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
Time Frame
The last three weeks of treatment (Weeks 11, 12, and 13)
Title
Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
Description
The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
Time Frame
Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)
Title
Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
Description
iPTH control was defined as a ≥ 50% reduction from baseline. iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory.
Time Frame
Weeks 2 to 13
Title
Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL
Description
iPTH control was defined as being within the target range of 60 to 180 pg/mL. iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory.
Time Frame
Weeks 2 to 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders On three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus (P) less than or equal to 6.5 mg/dL. Exclusion Criteria: Patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes Patients who have received a parathyroidectomy or ethanol infusion within the prior year Patients taking drugs that affect iPTH, calcium or bone metabolism Patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin) Female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuya Kobayashi, BA
Organizational Affiliation
AbbVie GK.
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 53485
City
Aichi
Country
Japan
Facility Name
Site Reference ID/Investigator# 51571
City
Chiba
Country
Japan
Facility Name
Site Reference ID/Investigator# 52963
City
Chiba
Country
Japan
Facility Name
Site Reference ID/Investigator# 52966
City
Chiba
Country
Japan
Facility Name
Site Reference ID/Investigator# 51578
City
Gifu
Country
Japan
Facility Name
Site Reference ID/Investigator# 52965
City
Gunma
Country
Japan
Facility Name
Site Reference ID/Investigator# 53782
City
Hadano-City
Country
Japan
Facility Name
Site Reference ID/Investigator# 57483
City
Himeji-City
Country
Japan
Facility Name
Site Reference ID/Investigator# 57487
City
Hokkaido
Country
Japan
Facility Name
Site Reference ID/Investigator# 53484
City
Hyogo
Country
Japan
Facility Name
Site Reference ID/Investigator# 54385
City
Ibaraki
Country
Japan
Facility Name
Site Reference ID/Investigator# 51581
City
Kagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59164
City
Kagoshima
Country
Japan
Facility Name
Site Reference ID/Investigator# 51574
City
Kanagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 51575
City
Kanagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 52751
City
Kodaira
Country
Japan
Facility Name
Site Reference ID/Investigator# 62025
City
Koga
Country
Japan
Facility Name
Site Reference ID/Investigator# 54384
City
Matsumoto
Country
Japan
Facility Name
Site Reference ID/Investigator# 52745
City
Midori
Country
Japan
Facility Name
Site Reference ID/Investigator# 51569
City
Mito
Country
Japan
Facility Name
Site Reference ID/Investigator# 52964
City
Nagano
Country
Japan
Facility Name
Site Reference ID/Investigator# 53483
City
Nagano
Country
Japan
Facility Name
Site Reference ID/Investigator# 51582
City
Nagasaki
Country
Japan
Facility Name
Site Reference ID/Investigator# 54388
City
Nagoya
Country
Japan
Facility Name
Site Reference ID/Investigator# 51576
City
Niigata
Country
Japan
Facility Name
Site Reference ID/Investigator# 51577
City
Niigata
Country
Japan
Facility Name
Site Reference ID/Investigator# 51580
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 52747
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 52748
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 52750
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 51570
City
Saitama
Country
Japan
Facility Name
Site Reference ID/Investigator# 54387
City
Sakai
Country
Japan
Facility Name
Site Reference ID/Investigator# 52746
City
Sapporo
Country
Japan
Facility Name
Site Reference ID/Investigator# 51579
City
Shizuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 62024
City
Takasaki
Country
Japan
Facility Name
Site Reference ID/Investigator# 51572
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 52752
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 53482
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59162
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59966
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 53783
City
Tomakomai-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 54383
City
Toyama
Country
Japan
Facility Name
Site Reference ID/Investigator# 52749
City
Wakayama
Country
Japan
Facility Name
Site Reference ID/Investigator# 52962
City
Yachiyoshi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59163
City
Yokohama-Shi
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://rxabbvie.com
Description
Related Info

Learn more about this trial

Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

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