Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism

NCT00990704 | Completed Phase 2 Results

• 1 other identifier: M11-609
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 14

Brief Summary

This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.

Conditions

Secondary Hyperparathyroidism; Hemodialysis

Keywords

Secondary hyperparathyroidism; Hemodialysis; paricalcitol; maxacalcitol

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.

  Baseline and the last 3 weeks (Weeks 11, 12, and 13)

Secondary Outcomes (7)

• The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks

  During the last 3 weeks (Weeks 11, 12, and 13)

• Mean iPTH at Each Visit

  Screening (up to 2 weeks before Baseline) to Week 13

• Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks

  Baseline and the last 3 weeks (Weeks 11, 12, and 13)

• Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment

  Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia

• Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment

  Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia

Study Arms (2)

Paricalcitol

EXPERIMENTAL

2 mcg adjusted by +/- 1 mcg, up to a maximum of 7 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis

Drug: paricalcitol

Maxacalcitol

ACTIVE COMPARATOR

5 or 10 mcg adjusted by +/- 2.5 mcg, up to a maximum of 20 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis

Drug: maxacalcitol

Interventions

paricalcitol DRUG

Intravenous administration 3 times a week immediately before completion of dialysis

Also known as: ABT-358, Zemplar

Paricalcitol

maxacalcitol DRUG

Intravenous administration 3 times a week immediately before completion of dialysis

Maxacalcitol

Eligibility Criteria

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

You may qualify if:

• Chronic kidney disease (CKD) patients with iPTH \>=300 pg/mL, adjusted calcium \>=8.4 to \<10.2 mg/dL, and phosphorus \<=6.5 mg/dL
• Patients receiving dialysis 3 times weekly for at least 3 months before informed consent was obtained and scheduled to receive the same hemodialysis during the study period
• Patients using dialysate with constant concentration of calcium for 4 weeks before informed consent was obtained and receiving phosphate binder with constant dose regimen for 2 weeks before informed consent was obtained

You may not qualify if:

• Patients taking drugs that affect iPTH, calcium, or bone metabolism
• Patients with a history of allergic reaction or significant sensitivity to vitamin D
• Patients who received parathyroidectomy or ethanol infusion within 1 year before informed consent was obtained
• Patients with malignancy or with clinically significant hepatic disease (liver function tests more than 3 times the upper limit of normal) or with refractory hepatic disease
• Patients with cardiovascular disease designated as New York Heart Association Class III or IV or with any of the following cardiovascular or cerebrovascular diseases within 6 months before informed consent was obtained:
• Acute coronary syndrome (myocardial infarction or unstable angina) or acute cerebral vascular disease (cerebral infarction or cerebral hemorrhage)
• Coronary arterial revascularization (such as coronary artery bypass grafting, percutaneous transluminal coronary angioplasty)
• Cerebral arterial revascularization (such as cerebral aneurysm clipping, cerebral aneurysm embolization, carotid artery endarterectomy)
• Arteriosclerosis obliterans with rest pain (Fontaine classification III or more severe)
• Patients with severe hypertension (defined as mean resting blood pressure taken with the patient in a supine position before dialysis and at 6 dialyses sessions before informed consent was obtained: systolic \>= 180 mmHg and diastolic \>= 110 mmHg)
• Patients with uncontrolled diabetes mellitus (defined as mean glycosylated hemoglobin \>=8% for 3 months before informed consent was obtained)
• Patients with a history of drug or alcohol abuse within 6 months before informed consent was obtained
• Patients who require chronic use of cytochrome P450 (CYP3A) inhibitors or inducers
• Patients who are taking products that contain aluminum 2 weeks before informed consent was obtained
• Patients who have taken paricalcitol in the past

Sponsors & Collaborators

• Abbott: lead

Study Sites (14)

Site Ref # / Investigator 53794

Anjo, Japan

Location

Site Ref # / Investigator 53787

Chiba, Japan

Location

Site Ref # / Investigator 53786

Kumagaya, Japan

Location

Site Ref # / Investigator 53792

Matsumoto, Japan

Location

Site Ref # / Investigator 53784

Mito, Japan

Location

Site Ref # / Investigator 53796

Nagasaki, Japan

Location

Site Ref # / Investigator 53795

Osaka, Japan

Location

Site Ref # / Investigator 21561

Sapporo, Japan

Location

Site Ref # / Investigator 53789

Tokyo, Japan

Location

Site Ref # / Investigator 53790

Tokyo, Japan

Location

Site Ref # / Investigator 53793

Toyohashi, Japan

Location

Site Ref # / Investigator 53785

Tsuchiura, Japan

Location

Site Ref # / Investigator 53788

Yachiyo, Japan

Location

Site Ref # / Investigator 53791

Yokosuka, Japan

Location

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: Abbott

800-633-9110

Study Officials

• Moriaki Kubo

  Abbott Japan Co.,Ltd

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 7, 2009
• Study Start: October 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 11, 2011
• Results First Posted: June 17, 2011

Record last verified: 2011-06

Locations

JP (14)