20070360 Incident Dialysis
Tracking InformationStart Date ICMJE | February 2009 |
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Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: December 4, 2008) | Achievement of a 30% reduction in mean PTH from baseline to during the efficacy assessment phase at month 6 (weeks 22 to 26) [ Time Frame: From Baseline to during the efficacy assessment phase at month 6 (weeks 22 to 26) ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00803712 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: December 4, 2008) | - Achievement within the specified treatment targets for PTH; Ca; and P during the efficacy assessment phase at month 6 (weeks 22 to 26) [ Time Frame: During the efficacy assessment phase at month 6 (weeks 22 to 26) ] [ Designated as safety issue: No ]
- Achievement of a greater than or equal to 30% reduction in mean PTH from baseline to during the efficacy assessment phase at month 12 (weeks 48 to 52) [ Time Frame: Baseline to during the efficacy assessment phase at month 12 (weeks 48 to 52) ] [ Designated as safety issue: No ]
- Achievement within the specified treatment targets for PTH; Ca; and P during both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52) [ Time Frame: During both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52) ] [ Designated as safety issue: No ]
- Absolute values and percent changes from baseline for PTH, Ca, and P [ Time Frame: The efficacy assessment phase at month 6 (weeks 22 to 26) and the efficacy assessment phase at month 12 (weeks 48 to 52) ] [ Designated as safety issue: No ]
- Achievement within the specified treatment targets for PTH; Ca; and P during the efficacy assessment phase at month 12 (weeks 48 to 52) [ Time Frame: During the efficacy assessment phase at month 12 (weeks 48 to 52) ] [ Designated as safety issue: No ]
- Achievement of a greater than or equal to 30% reduction in mean PTH from baseline to during both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52) [ Time Frame: From baseline to during both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52) ] [ Designated as safety issue: No ]
- Subject incidence of acute episodes of hypercalcemia / hyperphosphatemia [ Time Frame: The efficacy assessment phase at month 6 (weeks 22 to 26), the maintenance phase and the efficacy assessment phase at month 12 (weeks 48 to 52) ] [ Designated as safety issue: Yes ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | 20070360 Incident Dialysis |
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Official Title ICMJE | Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination With Low Dose Vitamin D for the Treatment of Subjects With Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis |
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Brief Summary | Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis |
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Detailed Description | |
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Study Phase | Phase IV |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | - Secondary Hyperparathyroidism
- Chronic Kidney Disease
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Intervention ICMJE | - Drug: Cinacalcet
Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt. Other Name: Sensipar/Mimpara - Drug: Vitamin D
Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism. Other Name: Active Vitamin D
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Study Arms / Comparison Groups | - Cinacalcet Group: Experimental
Cinacalcet plus low dose active Vitamin D (if prescibed) Intervention: Drug: Cinacalcet - Control Group: Active Comparator
Flexible active vitamin D dosing Intervention: Drug: Vitamin D
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Recruitment InformationEstimated Enrollment ICMJE | 300 |
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Estimated Completion Date | May 2012 |
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Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: - Adults greater than or equal to 18 years of age on hemodialysis for > 3 and less than or equal to 12 months prior to enrollment into the study
- Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 300 pg/mL (31.8 pmol/L); or biPTH > 160 pg/mL (17.0 pmol/L)
- Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L)
- Subject will be able to complete the study, to the best of his/her knowledge
- Before any study-specific procedure, the appropriate written informed consent must be obtained
Exclusion Criteria: - Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 800 pg/mL (84.9 pmol/L); or biPTH > 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening
- Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening
- Anticipated parathyroidectomy (partial or full) within 6 months after randomization
- Have a scheduled date for kidney transplant surgery
- Received cinacalcet since initiating hemodialysis
- Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening
- Subject is pregnant (eg, positive HCG test) or is breast-feeding
- Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment)
- Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
- Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance
- Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator
- Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).
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Gender | Both |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: Amgen Call Center | 866-572-6436 | | |
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Location Countries ICMJE | United States, Australia, Belgium, Canada, France, Germany, Greece, Hungary, Ireland, Italy, Norway, Russian Federation, Spain, United Kingdom |
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Administrative InformationNCT ID ICMJE | NCT00803712 |
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Responsible Party | Global Development Leader, Amgen Inc. |
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Study ID Numbers ICMJE | 20070360 |
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Study Sponsor ICMJE | Amgen |
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Collaborators ICMJE | |
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Investigators ICMJE | |
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Information Provided By | Amgen |
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