Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Study Overview
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Brief Summary
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Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Detailed Description
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Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.

Official Title
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A Phase 3b, Randomized, Active-Controlled, Single-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Injection in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects Receiving Hemodialysis

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: paricalcitol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a Chinese male or female greater than or equal to 20 years old. Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemodialysis for the duration of the study. For entry into the Treatment Phase, the subject must have: Intact parathyroid hormone greater than or equal to 300 pg/mL Serum calcium less than 10.2 mg/dL (2.55 mmol/L) Calcium-phosphorus product less than 65 mg^2/dL^2 Exclusion Criteria: Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds. Subject received a partial parathyroidectomy within one year prior to the Screening Phase. Subject with New York Heart Association (NYHA) Class III or IV. Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the Screening Phase, or requires such medications for greater than 3 weeks in the study. Subject has a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the Investigator. Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase. Subject is known to be human immunodeficiency virus (HIV) positive. Subject has evidence of poor compliance with diet, medication or hemodialysis that may interfere, in the Investigator's opinion, with adherence to the protocol.

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL). | Drug: paricalcitol<br>* Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.<br>* Other names: Zemplar;|
| Active Comparator: Group 2<br>Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg) | Drug: paricalcitol<br>* Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.<br>* Other names: Zemplar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels | The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values | Baseline to 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL | The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL | Baseline to 12 Weeks | 
| The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value |  | Baseline to 12 Weeks | 
| The Change From Baseline to the Final Observation in Calcium |  | Baseline to 12 Weeks | 
| The Change From Baseline to the Final Observation in Calcium-phosphorus Product |  | Baseline to 12 Weeks | 
| The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure |  | Baseline to 12 Weeks | 
| The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure |  | Baseline to 12 Weeks | 
| The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate |  | Baseline to 12 Weeks | 
| The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L) | The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L) | Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Secondary hyperparathyroidism