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Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis

Primary Purpose

Chronic Kidney Disease on Hemodialysis, Secondary Hyperparathyroidism

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Maxacalcitol
Paricalcitol
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease on Hemodialysis focused on measuring chronic kidney disease, secondary hyperparathyroidism, hemodialysis, paricalcitol, maxacalcitol

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period.
  • Using dialysate with constant concentration of calcium for 4 weeks prior to obtaining informed consent and phosphate binder with constant dose regimen for 2 weeks prior to obtaining informed consent.
  • Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL
  • Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL)
  • Phosphorus ≤ 6.5 mg/dL
  • Age ≥ 20 years

Exclusion Criteria:

  • History of allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds
  • Parathyroidectomy or ethanol infusion within past year
  • Progressive malignancy or clinically significant hepatic diseases, severe cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes mellitus
  • Drug or alcohol abuse within past 6 months
  • Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet, bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism (other than estrogen or progestin, vitamin K2)
  • Will need to take chronic dose (≥ 2 consecutive weeks) of cytochrome P450 (CYP3A) inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
  • Taking aluminum containing products (2 weeks prior to consent)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

Paricalcitol 2 µg ± 1 µg

Paricalcitol 2 µg ± 2 µg

Paricalcitol 4 µg ± 1 µg

Paricalcitol 4 µg ± 2 µg

Maxacalcitol 5 or 10 µg ± 2.5 µg

Arm Description

Paricalcitol initial dosage 2 micrograms (µg) with incremental adjustment of 1 µg

Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg

Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg

Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg

Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg

Outcomes

Primary Outcome Measures

Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level

Secondary Outcome Measures

Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level
Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)
Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level
Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values
Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL

Full Information

First Posted
April 24, 2008
Last Updated
January 18, 2012
Sponsor
Abbott
Collaborators
Abbott Japan Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00667576
Brief Title
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
Official Title
Late Phase 2 Study of Paricalcitol Injection: Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism (Examination of Initial Dose and Incremental Dose)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
Collaborators
Abbott Japan Co.,Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.
Detailed Description
This multicenter, randomized, open-label trial consisted of 4 dose-adjustment regimens for paricalcitol injection (initial doses and dose adjustment ranges were 2 ± 1 µg, 2 ± 2 µg, 4 ± 1 µg, and 4 ± 2 µg) and 1 maxacalcitol regimen (initial dose and dose adjustment range was 5 µg ± 2.5 µg or 10 µg ± 2.5 µg) as a reference group. Subjects who met the inclusion criteria were randomized equally to 1 of the treatment groups with iPTH values at screening (< 500 pg/mL or ≥ 500 pg/mL) as a dynamic allocation factor. Study drugs were administered 3 times weekly (every other day) from the venous end of the hemodialysis circuit just before completion of the dialysis session. The initial doses were continued for 2 weeks, followed by dose adjustments (increase, maintenance, decrease, suspension, or resumption) by 1 µg or 2 µg units for the paricalcitol groups and by 2.5 µg units for the maxacalcitol group based on iPTH, calcium (adjusted), and phosphorus values every 2 weeks. Subjects in the paricalcitol groups were to be suspended from treatment if their iPTH value decreased to < 60 pg/mL in accordance with the guidelines proposed by the Japanese Society of Dialysis Therapy for the treatment of secondary hyperparathyroidism in chronic dialysis patients (control goal value of 60-180 pg/mL for iPTH). The dose adjustment criteria based on iPTH values for the maxacalcitol group were set according to the prescribing information for maxacalcitol (suspended when iPTH decreased to ≤ 150 pg/mL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease on Hemodialysis, Secondary Hyperparathyroidism
Keywords
chronic kidney disease, secondary hyperparathyroidism, hemodialysis, paricalcitol, maxacalcitol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol 2 µg ± 1 µg
Arm Type
Experimental
Arm Description
Paricalcitol initial dosage 2 micrograms (µg) with incremental adjustment of 1 µg
Arm Title
Paricalcitol 2 µg ± 2 µg
Arm Type
Experimental
Arm Description
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
Arm Title
Paricalcitol 4 µg ± 1 µg
Arm Type
Experimental
Arm Description
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
Arm Title
Paricalcitol 4 µg ± 2 µg
Arm Type
Experimental
Arm Description
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
Arm Title
Maxacalcitol 5 or 10 µg ± 2.5 µg
Arm Type
Other
Arm Description
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
Intervention Type
Drug
Intervention Name(s)
Maxacalcitol
Intervention Description
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 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Other Intervention Name(s)
ABT-358, Zemplar
Intervention Description
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 12 weeks.
Primary Outcome Measure Information:
Title
Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level
Time Frame
Baseline to Week 13 (Final Visit)
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level
Time Frame
Baseline to Week 13 (Final Visit)
Title
Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)
Time Frame
Baseline to Week 13 (Final Visit)
Title
Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level
Time Frame
Through Week 13
Title
Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values
Time Frame
Through Week 13
Title
Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL
Time Frame
Through Week 13
Other Pre-specified Outcome Measures:
Title
Percentage of Subjects With Hypercalcemia
Description
Hypercalcemia was defined as at least 1 adjusted calcium value > 11.5 mg/dL or at least 2 consecutive adjusted calcium values ≥ 11.0 mg/dL
Time Frame
Through Week 13
Title
Percentage of Subjects With Hyperphosphatemia
Description
Hyperphosphatemia was defined as at least 2 consecutive phosphorus values ≥ 7.0 mg/dL
Time Frame
Through Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period. Using dialysate with constant concentration of calcium for 4 weeks prior to obtaining informed consent and phosphate binder with constant dose regimen for 2 weeks prior to obtaining informed consent. Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL) Phosphorus ≤ 6.5 mg/dL Age ≥ 20 years Exclusion Criteria: History of allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds Parathyroidectomy or ethanol infusion within past year Progressive malignancy or clinically significant hepatic diseases, severe cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes mellitus Drug or alcohol abuse within past 6 months Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet, bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism (other than estrogen or progestin, vitamin K2) Will need to take chronic dose (≥ 2 consecutive weeks) of cytochrome P450 (CYP3A) inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin) Taking aluminum containing products (2 weeks prior to consent)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryotaro Matsuzawa
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
City
Tokyo
State/Province
Metropolis
Country
Japan
City
Aichi
State/Province
Prefecture
Country
Japan
City
Chiba
State/Province
Prefecture
Country
Japan
City
Fukuoka
State/Province
Prefecture
Country
Japan
City
Hokkaido
State/Province
Prefecture
Country
Japan
City
Ibaragi
State/Province
Prefecture
Country
Japan
City
Kanagawa
State/Province
Prefecture
Country
Japan
City
Kumamoto
State/Province
Prefecture
Country
Japan
City
Nagano
State/Province
Prefecture
Country
Japan
City
Nagasaki
State/Province
Prefecture
Country
Japan
City
Osaka
State/Province
Prefecture
Country
Japan
City
Saitama
State/Province
Prefecture
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis

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