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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Secondary Hyperparathyroidism, Hemodialysis

Intervention / Treatment
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* Drug: paricalcitol
* Drug: maxacalcitol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paricalcitol<br>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<br>* Intravenous administration 3 times a week immediately before completion of dialysis<br>* Other names: Zemplar;|
| Active Comparator: Maxacalcitol<br>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<br>* Intravenous administration 3 times a week immediately before completion of dialysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL. | 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 | Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL. | Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia | 
| Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline |  | Over the 12-week treatment period | 
| Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH |  | Over the 12-week treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary hyperparathyroidism, Hemodialysis, paricalcitol, maxacalcitol