Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01181531
First received: August 12, 2010
Last updated: March 28, 2014
Last verified: March 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperparathyroidism, Secondary |
Drug: Traditional Vitamin D Therapy Drug: Cinacalcet |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to week 40-52 ] [ Designated as safety issue: No ]Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52
Secondary Outcome Measures:
- Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to week 40-52 ] [ Designated as safety issue: No ]Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
- Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP) [ Time Frame: week 40-52 ] [ Designated as safety issue: No ]Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)
| Enrollment: | 312 |
| Study Start Date: | October 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Traditional Vitamin D Therapy |
Drug: Traditional Vitamin D Therapy
Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT) in this study will be administered according to strategies that have been used in clinical practice and that conform to current therapeutic recommendations and available clinical practice guidelines and product labeling.
|
| Experimental: Cinacalcet |
Drug: Cinacalcet
Subjects randomized to treatment with cinacalcet will receive an initial oral dose of 30 mg once daily. Doses will be titrated incrementally to 60, 90,120, and 180 mg per day based upon periodic measurements of serum calcium and plasma PTH levels. Cinacalcet is formulated as light green tablets in 30, 60, and 90 mg free-based equivalents. Tablets will be 30, 60, and 90 mg, graduated in size, smallest to largest. Combinations of these 3 fixed dosage formulations will be used to achieve the 120 and 180 mg daily doses.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01181531
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181531
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01181531 History of Changes |
| Other Study ID Numbers: | 20090686, PARADIGM |
| Study First Received: | August 12, 2010 |
| Results First Received: | December 3, 2013 |
| Last Updated: | March 28, 2014 |
| Health Authority: | Australia: Therapeutic Goods Administration Canada: Health Canada Canada: Institutional Review Board Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health) Russia: Ministry of Health United States: Food and Drug Administration United States: Western Institutional Review Board |
Keywords provided by Amgen:
|
Secondary Hyperthyroidism Hemodialysis Parathyroid PARADIGM |
Additional relevant MeSH terms:
|
Hyperparathyroidism Hyperparathyroidism, Secondary Neoplasm Metastasis Endocrine System Diseases Neoplasms Neoplastic Processes Parathyroid Diseases Pathologic Processes |
Ergocalciferols Vitamin D Vitamins Bone Density Conservation Agents Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015