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

Amgen

Status and phase

Completed

Phase 4

Conditions

Hyperparathyroidism, Secondary

Treatments

Drug: Cinacalcet

Drug: Traditional Vitamin D Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT01181531

PARADIGM (Other Identifier)

20090686

Details and patient eligibility

About

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.

Enrollment

312 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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