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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperparathyroidism, Secondary Endocrine System Diseases Hyperparathyroidism Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional Vitamin D Therapy

Drug

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.

Cinacalcet

Drug

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.

Primary outcomes

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 outcomes

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)
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)

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Aug 13, 2010
Registry last updated: Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed