Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.

Official Title
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A Multicenter, Randomized, Open Label Study to Compare the Efficacy of Cinacalcet Versus Traditional Vitamin D Therapy for Management of Secondary Hyperparathyroidism Among Subjects Undergoing Hemodialysis

Conditions
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Hyperparathyroidism, Secondary

Intervention / Treatment
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* Drug: Traditional Vitamin D Therapy
* Drug: Cinacalcet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years at screening Treated with maintenance hemodialysis 3 times a week for ≥ 3 months prior to screening Informed consent provided by the study candidate For subjects NOT receiving cinacalcet and/or vitamin D therapy for SHPT within 60 days prior to enrollment: Plasma PTH levels ≥ 450 pg/mL (50 pmol/L) during screening, as obtained from the central laboratory and, Serum corrected total calcium ≥ 8.4 mg/dL (2.1 mmol/L) and < 10.2 mg/dL (2.55 mmol/L) during screening, as obtained from the central laboratory Exclusion Criteria: Parathyroidectomy in the 12 weeks before the date of informed consent History of seizure within 12 weeks prior to randomization Scheduled for kidney transplant Parathyroidectomy anticipated within the next 6 months Liver function tests > than 2 x the Upper Limit of Normal Prior use of bisphosphonates, or expected to receive bisphosphonates during the trial Subject has previously enrolled in this study General Other investigational procedures are excluded Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) Subject (male or female) is not willing to use highly effective contraception during treatment and for at least one month (women) and 3 months (men) after the end of treatment Subject is pregnant or breast feeding, or planning to become pregnant during study or within 1 month after the end of treatment Male subject with a pregnant partner who is not willing to use a condom during treatment and for at least 1 month after the end of treatment Subject has known sensitivity or intolerance to any of the protocol required therapies Subject will not be available for protocol-required study visits, to the best of the subject and investigator's knowledge Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Traditional Vitamin D Therapy<br> | Drug: Traditional Vitamin D Therapy<br>* Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT) in this study will be administered according to strategies that have been used in clinical practice and that conform to current therapeutic recommendations and available clinical practice guidelines and product labeling.<br>|
| Experimental: Cinacalcet<br> | Drug: Cinacalcet<br>* Subjects randomized to treatment with cinacalcet will receive an initial oral dose of 30 mg once daily. Doses will be titrated incrementally to 60, 90,120, and 180 mg per day based upon periodic measurements of serum calcium and plasma PTH levels. Cinacalcet is formulated as light green tablets in 30, 60, and 90 mg free-based equivalents. Tablets will be 30, 60, and 90 mg, graduated in size, smallest to largest. Combinations of these 3 fixed dosage formulations will be used to achieve the 120 and 180 mg daily doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP) | Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52 | Baseline to week 40-52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP) | Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP) | Baseline to week 40-52 | 
| Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP) | Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP) | week 40-52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary Hyperthyroidism, Hemodialysis, Parathyroid, PARADIGM