Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00990704
First received: October 5, 2009
Last updated: June 30, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Secondary Hyperparathyroidism Hemodialysis |
Drug: paricalcitol Drug: maxacalcitol |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- 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. [ Time Frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: During the last 3 weeks (Weeks 11, 12, and 13) ] [ Designated as safety issue: No ]
- Mean iPTH at Each Visit [ Time Frame: Screening (up to 2 weeks before Baseline) to Week 13 ] [ Designated as safety issue: No ]
- Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks [ Time Frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13) ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia ] [ Designated as safety issue: Yes ]Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.
- 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 [ Time Frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia ] [ Designated as safety issue: Yes ]Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.
- Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
- Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
| Enrollment: | 47 |
| Study Start Date: | October 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paricalcitol
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
Intravenous administration 3 times a week immediately before completion of dialysis
Other Names:
|
|
Active Comparator: Maxacalcitol
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
Intravenous administration 3 times a week immediately before completion of dialysis
Other Name: maxacalcitol
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990704
Locations
| Japan | |
| Site Ref # / Investigator 53794 | |
| Anjo, Japan | |
| Site Ref # / Investigator 53787 | |
| Chiba, Japan | |
| Site Ref # / Investigator 53786 | |
| Kumagaya, Japan | |
| Site Ref # / Investigator 53792 | |
| Matsumoto, Japan | |
| Site Ref # / Investigator 53784 | |
| Mito, Japan | |
| Site Ref # / Investigator 53796 | |
| Nagasaki, Japan | |
| Site Ref # / Investigator 53795 | |
| Osaka, Japan | |
| Site Ref # / Investigator 21561 | |
| Sapporo, Japan | |
| Site Ref # / Investigator 53790 | |
| Tokyo, Japan | |
| Site Ref # / Investigator 53789 | |
| Tokyo, Japan | |
| Site Ref # / Investigator 53793 | |
| Toyohashi, Japan | |
| Site Ref # / Investigator 53785 | |
| Tsuchiura, Japan | |
| Site Ref # / Investigator 53788 | |
| Yachiyo, Japan | |
| Site Ref # / Investigator 53791 | |
| Yokosuka, Japan | |
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Moriaki Kubo | Abbott Japan Co.,Ltd |
More Information
No publications provided
| Responsible Party: | Yoshihiko Ueki, Abbott |
| ClinicalTrials.gov Identifier: | NCT00990704 History of Changes |
| Other Study ID Numbers: | M11-609 |
| Study First Received: | October 5, 2009 |
| Results First Received: | May 20, 2011 |
| Last Updated: | June 30, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Abbott:
|
Secondary hyperparathyroidism Hemodialysis paricalcitol maxacalcitol |
Additional relevant MeSH terms:
|
Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Parathyroid Diseases Endocrine System Diseases Urologic Diseases Renal Insufficiency Maxacalcitol Calcitriol Ergocalciferols Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Dermatologic Agents Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013