Clinical trial NCT00990704: Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
Official title: Phase II, Open Study, Exploratory Examination of Efficacy and Safety of Paricalcitol Injection and Maxacalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism
Hemodialysis
Keywords: Secondary hyperparathyroidism
Hemodialysis
paricalcitol
maxacalcitol
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: Baseline and the last 3 weeks (Weeks 11, 12, and 13)
Secondary outcomes:
measure: 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
timeFrame: During the last 3 weeks (Weeks 11, 12, and 13)
measure: Mean iPTH at Each Visit
timeFrame: Screening (up to 2 weeks before Baseline) to Week 13
measure: Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks
timeFrame: Baseline and the last 3 weeks (Weeks 11, 12, and 13)
measure: 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
timeFrame: Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia
measure: 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
timeFrame: Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia
measure: Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline
timeFrame: Over the 12-week treatment period
measure: Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH
timeFrame: Over the 12-week treatment period
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Site Ref # / Investigator 53794
city: Chiba
country: Japan
facility: Site Ref # / Investigator 53787
city: Kumagaya
country: Japan
facility: Site Ref # / Investigator 53786
city: Matsumoto
country: Japan
facility: Site Ref # / Investigator 53792
city: Mito
country: Japan
facility: Site Ref # / Investigator 53784
city: Nagasaki
country: Japan
facility: Site Ref # / Investigator 53796
city: Osaka
country: Japan
facility: Site Ref # / Investigator 53795
city: Sapporo
country: Japan
facility: Site Ref # / Investigator 21561
city: Tokyo
country: Japan
facility: Site Ref # / Investigator 53789
city: Tokyo
country: Japan
facility: Site Ref # / Investigator 53790
city: Toyohashi
country: Japan
facility: Site Ref # / Investigator 53793
city: Tsuchiura
country: Japan
facility: Site Ref # / Investigator 53785
city: Yachiyo
country: Japan
facility: Site Ref # / Investigator 53788
city: Yokosuka
country: Japan
facility: Site Ref # / Investigator 53791
Study officials:
affiliation: Abbott Japan Co.,Ltd
name: Moriaki Kubo
role: STUDY_DIRECTOR
References: