Phase 4
Completed N=312
Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
Hyperparathyroidism, Secondary
Source: ClinicalTrials.gov NCT01181531 ↗
Enrolled (actual)
312
Serious AEs
41.6%
Results posted
Apr 2014
Primary outcomePrimary: Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP) — -7; -12.1 Percent change — p=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.
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 |
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. Informational only — not medical advice.