20070360 Incident Dialysis
Primary Purpose
Chronic Kidney Disease, Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cinacalcet
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cinacalcet Group
Control Group
Arm Description
Cinacalcet plus low dose active Vitamin D (if prescribed)
Flexible active vitamin D dosing
Outcomes
Primary Outcome Measures
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Secondary Outcome Measures
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6
Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
Subject Incidence of Hypercalcemia During the Maintenance Phase
Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12
Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6
Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL
Subject Incidence of Hyperphosphatemia During the Maintenance Phase
Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL
Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12
Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00803712
Brief Title
20070360 Incident Dialysis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2009 (Actual)
Primary Completion Date
December 9, 2010 (Actual)
Study Completion Date
July 5, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Secondary Hyperparathyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
313 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cinacalcet Group
Arm Type
Experimental
Arm Description
Cinacalcet plus low dose active Vitamin D (if prescribed)
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Flexible active vitamin D dosing
Intervention Type
Drug
Intervention Name(s)
Cinacalcet
Other Intervention Name(s)
Sensipar/Mimpara
Intervention Description
Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Active Vitamin D
Intervention Description
Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.
Primary Outcome Measure Information:
Title
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Description
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26
Secondary Outcome Measure Information:
Title
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Description
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26
Title
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Description
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 48-52
Title
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Description
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 48-52
Title
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Description
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26
Title
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Description
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 48-52
Title
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Description
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26
Title
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Description
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 48-52
Title
Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26 and Weeks 48-52
Title
Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26 and Weeks 48-52
Title
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26 and Weeks 48-52
Title
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26 and Weeks 48-52
Title
Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26
Title
Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26
Title
Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 48-52
Title
Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 48-52
Title
Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26
Title
Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26
Title
Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 48-52
Title
Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 48-52
Title
Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26
Title
Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 22-26
Title
Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 48-52
Title
Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase
Description
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Time Frame
Weeks 48-52
Title
Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6
Description
Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
Time Frame
Weeks 22-26
Title
Subject Incidence of Hypercalcemia During the Maintenance Phase
Description
Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
Time Frame
Weeks 26-48
Title
Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12
Description
Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
Time Frame
Weeks 48-52
Title
Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6
Description
Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL
Time Frame
Weeks 22-26
Title
Subject Incidence of Hyperphosphatemia During the Maintenance Phase
Description
Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL
Time Frame
Weeks 26-48
Title
Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12
Description
Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL
Time Frame
Weeks 48-52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23365129
Citation
Rodriguez M, Urena-Torres P, Petavy F, Cooper K, Farouk M, Goodman WG. Calcium-mediated parathyroid hormone suppression to assess progression of secondary hyperparathyroidism during treatment among incident dialysis patients. J Clin Endocrinol Metab. 2013 Feb;98(2):618-25. doi: 10.1210/jc.2012-3246. Epub 2013 Jan 30.
Results Reference
background
PubMed Identifier
23328710
Citation
Urena-Torres P, Bridges I, Christiano C, Cournoyer SH, Cooper K, Farouk M, Kopyt NP, Rodriguez M, Zehnder D, Covic A. Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism. Nephrol Dial Transplant. 2013 May;28(5):1241-54. doi: 10.1093/ndt/gfs568. Epub 2013 Jan 16.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
20070360 Incident Dialysis
We'll reach out to this number within 24 hrs