Neoplasms

Symptoms and General Pathology

All Conditions

Gland and Hormone Related Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Hyperthyroidism

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Micronutrients

Vasoconstrictor Agents

Vitamins

Cinacalcet

Vitamin D

Cholecalciferol

Calcium

Alfacalcidol

Hydroxycholecalciferols

Calcium, Dietary

Calcitriol

Parathyroid Hormone

1 alpha-hydroxyergocalciferol

Trace Elements

Hormones

Hormone Antagonists

Vitamin D3

Calciferol

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.

Traditional Vitamin D Therapy

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.

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.

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

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

Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52

Number of participants achieving a \>=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)

Number of participants achieving Plasma PTH \< 300 pg/mL During Efficacy Assessment Phase (EAP)

Amgen

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.

Vitamin D sterol, intravenous (IV) or oral

Traditional Vitamin D

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or Not Reported

Race/Ethnicity, Customized

Study Director

Null hypothesis: no difference in % change from baseline in PTH comparing the two treatment arms.

All subjects randomized by treatment arm.

Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)

Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)

Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)

Overall Study

Spots Global Cancer Trial Database for Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial