18 and older, any sex, with Chronic Kidney Disease or Secondary Hyperparathyroidism. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)Primary· Weeks 22-26
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.
Responders defined as >= 30% reduction in Mean PTH
Group
Value
95% CI
Cinacalcet
96
Control Group
58
Non responders
Group
Value
95% CI
Cinacalcet
57
Control Group
93
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)Secondary· Weeks 22-26
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.
Responders defined as a mean PTH <= 300 pg/mL
Group
Value
95% CI
Cinacalcet
87
Control Group
53
Non responders
Group
Value
95% CI
Cinacalcet
66
Control Group
98
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)Secondary· Weeks 48-52
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.
Responders defined as >= 30% reduction in mean PTH
Group
Value
95% CI
Cinacalcet
97
Control Group
72
Non responders
Group
Value
95% CI
Cinacalcet
56
Control Group
79
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)Secondary· Weeks 48-52
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.
Responders defined as a mean PTH <= 300 pg/mL
Group
Value
95% CI
Cinacalcet
80
Control Group
67
Non responders
Group
Value
95% CI
Cinacalcet
73
Control Group
84
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)Secondary· Weeks 22-26
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.
Responders, a mean corrected calcium < 10.2 mg/dL
Group
Value
95% CI
Cinacalcet
151
Control Group
144
Non responders
Group
Value
95% CI
Cinacalcet
2
Control Group
7
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)Secondary· Weeks 48-52
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.
Responders, a mean corrected calcium < 10.2 mg/dL
Group
Value
95% CI
Cinacalcet
146
Control Group
141
Non responders
Group
Value
95% CI
Cinacalcet
7
Control Group
10
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)Secondary· Weeks 22-26
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.
Responders, a mean phosphorus < 5.5 mg/dL
Group
Value
95% CI
Cinacalcet
100
Control Group
85
Non responders
Group
Value
95% CI
Cinacalcet
53
Control Group
66
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)Secondary· Weeks 48-52
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.
Responders, a mean serum phosphorus < 5.5 mg/dL
Group
Value
95% CI
Cinacalcet
81
Control Group
80
Non responders
Group
Value
95% CI
Cinacalcet
72
Control Group
71
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)Secondary· Weeks 22-26 and Weeks 48-52
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.
Responders, a >= 30% reduction in mean iPTH
Group
Value
95% CI
Cinacalcet
74
Control Group
42
Non responders
Group
Value
95% CI
Cinacalcet
79
Control Group
109
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)Secondary· Weeks 22-26 and Weeks 48-52
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.
Responders, a mean iPTH <= 300 pg/mL
Group
Value
95% CI
Cinacalcet
54
Control Group
39
Non responders
Group
Value
95% CI
Cinacalcet
99
Control Group
112
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)Secondary· Weeks 22-26 and Weeks 48-52
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.
Responders, a mean corrected calcium < 10.2 mg/dL
Group
Value
95% CI
Cinacalcet
145
Control Group
139
Non responders
Group
Value
95% CI
Cinacalcet
8
Control Group
12
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)Secondary· Weeks 22-26 and Weeks 48-52
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.
Responders, a mean serum phosphorus < 5.5 mg/dL
Group
Value
95% CI
Cinacalcet
71
Control Group
64
Non responders
Group
Value
95% CI
Cinacalcet
82
Control Group
87
Adverse events — posted to ClinicalTrials.gov
Time frame: 56 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 17 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00803712.