Phase 4
N=312
Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
Hyperparathyroidism, Secondary
Bottom Line
View on ClinicalTrials.gov: NCT01181531 ↗Enrolled (actual)
312
Serious AEs
41.6%
Results posted
Apr 2014
Primary outcome: Primary: Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP) — -7; -12.1 Percent change — p=0.346
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Traditional Vitamin D Therapy (Drug); Cinacalcet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP) |
-7; -12.1 | 0.346 |
| SECONDARY Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP) |
53; 66; 104; 89 | 0.110 |
| SECONDARY Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP) |
24; 30; 133; 125 | 0.346 |
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 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
Data sourced from ClinicalTrials.gov (NCT01181531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.