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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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

paricalcitol

maxacalcitol

paricalcitol placebo

maxacalcitol placebo

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.

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

NCT ID

NCT01341782

First Posted

April 25, 2011

Last Updated

April 17, 2013

Sponsor

AbbVie (prior sponsor, Abbott)

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

Secondary Hyperparathyroidism, Hemodialysis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial