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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hyperparathyroidism, Secondary	Drug: Traditional Vitamin D Therapy; Drug: Cinacalcet	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	312 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	October 2010
Actual Primary Completion Date :	August 2012
Actual Study Completion Date :	October 2012

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Traditional Vitamin D Therapy	Drug: Traditional Vitamin D Therapy; 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.
Experimental: Cinacalcet	Drug: Cinacalcet; 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.

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to week 40-52 ]
   Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
2. Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP) [ Time Frame: week 40-52 ]
   Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Sponsors and Collaborators

Amgen

Investigators

Study Director:	MD	Amgen

More Information

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Additional Information:

AmgenTrials clinical trials website 

Publications:

Wetmore JB, Gurevich K, Sprague S, Da Roza G, Buerkert J, Reiner M, Goodman W, Cooper K. A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM). Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1031-40. doi: 10.2215/CJN.07050714. Epub 2015 Apr 22.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sprague SM, Wetmore JB, Gurevich K, Da Roza G, Buerkert J, Reiner M, Goodman W, Cooper K. Effect of Cinacalcet and Vitamin D Analogs on Fibroblast Growth Factor-23 during the Treatment of Secondary Hyperparathyroidism. Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1021-30. doi: 10.2215/CJN.03270314. Epub 2015 Apr 14.

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01181531 History of Changes
Other Study ID Numbers:	20090686; PARADIGM ( Other Identifier: Amgen )
First Posted:	August 13, 2010
Results First Posted:	April 25, 2014
Last Update Posted:	March 15, 2017
Last Verified:	February 2017

Keywords provided by Amgen:

Secondary Hyperthyroidism; Hemodialysis; Parathyroid; PARADIGM

Additional relevant MeSH terms:

Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary; Neoplastic Processes; Neoplasms; Pathologic Processes; Parathyroid Diseases; Endocrine System Diseases; Vitamins; Vitamin D	Ergocalciferols; Cinacalcet Hydrochloride; Micronutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcimimetic Agents; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists