Clinical trial NCT01181531: Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperthyroidism
Hemodialysis
Parathyroid
PARADIGM
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
timeFrame: Baseline to week 40-52
Secondary outcomes:
measure: Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)
timeFrame: Baseline to week 40-52
measure: Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)
timeFrame: week 40-52
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.