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

NCT01341782 | Completed Phase 3 Results

• 1 other identifier: M11-517
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 45

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.

Conditions

Secondary Hyperparathyroidism; Hemodialysis

Keywords

Secondary hyperparathyroidism; Paricalcitol; Hemodialysis; Maxacalcitol

Outcome Measures

Primary Outcomes (1)

• 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.

  iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).

Secondary Outcomes (5)

• Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia

  Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).

• Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)

  The last three weeks of treatment (Weeks 11, 12, and 13)

• Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline

  Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)

• Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline

  Weeks 2 to 13

• Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL

  Weeks 2 to 13

Study Arms (2)

Paricalcitol

EXPERIMENTAL

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.

Drug: paricalcitol; Drug: maxacalcitol placebo

Maxacalcitol

ACTIVE COMPARATOR

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.

Drug: maxacalcitol; Drug: paricalcitol placebo

Interventions

paricalcitol DRUG

Also known as: ABT-358, Zemplar

Paricalcitol

maxacalcitol DRUG

Also known as: oxarol

Maxacalcitol

paricalcitol placebo DRUG

Maxacalcitol

maxacalcitol placebo DRUG

Paricalcitol

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (45)

Site Reference ID/Investigator# 53485

Aichi, Japan

Location

Site Reference ID/Investigator# 51571

Chiba, Japan

Location

Site Reference ID/Investigator# 52963

Chiba, Japan

Location

Site Reference ID/Investigator# 52966

Chiba, Japan

Location

Site Reference ID/Investigator# 51578

Gifu, Japan

Location

Site Reference ID/Investigator# 52965

Gunma, Japan

Location

Site Reference ID/Investigator# 53782

Hadano, Japan

Location

Site Reference ID/Investigator# 57483

Himeji, Japan

Location

Site Reference ID/Investigator# 57487

Hokkaido, Japan

Location

Site Reference ID/Investigator# 53484

Hyōgo, Japan

Location

Site Reference ID/Investigator# 54385

Ibaraki, Japan

Location

Site Reference ID/Investigator# 51581

Kagawa, Japan

Location

Site Reference ID/Investigator# 59164

Kagoshima, Japan

Location

Site Reference ID/Investigator# 51574

Kanagawa, Japan

Location

Site Reference ID/Investigator# 51575

Kanagawa, Japan

Location

Site Reference ID/Investigator# 52751

Kodaira, Japan

Location

Site Reference ID/Investigator# 62025

Koga, Japan

Location

Site Reference ID/Investigator# 54384

Matsumoto, Japan

Location

Site Reference ID/Investigator# 52745

Midori, Japan

Location

Site Reference ID/Investigator# 51569

Mito, Japan

Location

Site Reference ID/Investigator# 52964

Nagano, Japan

Location

Site Reference ID/Investigator# 53483

Nagano, Japan

Location

Site Reference ID/Investigator# 51582

Nagasaki, Japan

Location

Site Reference ID/Investigator# 54388

Nagoya, Japan

Location

Site Reference ID/Investigator# 51576

Niigata, Japan

Location

Site Reference ID/Investigator# 51577

Niigata, Japan

Location

Site Reference ID/Investigator# 51580

Osaka, Japan

Location

Site Reference ID/Investigator# 52747

Osaka, Japan

Location

Site Reference ID/Investigator# 52748

Osaka, Japan

Location

Site Reference ID/Investigator# 52750

Osaka, Japan

Location

Site Reference ID/Investigator# 51570

Saitama, Japan

Location

Site Reference ID/Investigator# 54387

Sakai, Japan

Location

Site Reference ID/Investigator# 52746

Sapporo, Japan

Location

Site Reference ID/Investigator# 51579

Shizuoka, Japan

Location

Site Reference ID/Investigator# 62024

Takasaki, Japan

Location

Site Reference ID/Investigator# 51572

Tokyo, Japan

Location

Site Reference ID/Investigator# 52752

Tokyo, Japan

Location

Site Reference ID/Investigator# 53482

Tokyo, Japan

Location

Site Reference ID/Investigator# 59162

Tokyo, Japan

Location

Site Reference ID/Investigator# 59966

Tokyo, Japan

Location

Site Reference ID/Investigator# 53783

Tomakomai-shi, Japan

Location

Site Reference ID/Investigator# 54383

Toyama, Japan

Location

Site Reference ID/Investigator# 52749

Wakayama, Japan

Location

Site Reference ID/Investigator# 52962

Yachiyoshi, Japan

Location

Site Reference ID/Investigator# 59163

Yokohama, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

paricalcitol; maxacalcitol

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbvie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Kazuya Kobayashi, BA

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 26, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 6, 2013
• Results First Posted: June 6, 2013

Record last verified: 2013-04

Locations

JP (45)