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

• Status: Completed
• Trial end date: 2012-08-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Cinacalcet; Cinacalcet Hydrochloride; Ergocalciferols; Vitamin D; Vitamins

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