20070360 Incident Dialysis

Phase 4

Completed

Conditions: Secondary Hyperparathyroidism
Chronic Kidney Disease

Interventions: Drug: Cinacalcet
Drug: Vitamin D

Registration Number: NCT00803712

Lead Sponsor: Amgen

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 313

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cinacalcet Group	Cinacalcet	Cinacalcet plus low dose active Vitamin D (if prescribed)
Control Group	Vitamin D	Flexible active vitamin D dosing

Primary Outcome Measures

Name	Time	Method
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)	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.

Secondary Outcome Measures

Name	Time	Method
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)	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.
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)	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.
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)	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.
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)	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.
Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase	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.
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)	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.
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)	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.
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)	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.
Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase	Weeks 22-26	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	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.
Subject Incidence of Hypercalcemia During the Maintenance Phase	Weeks 26-48	Hypercalcemia is defined as at least one corrected serum calcium value \>= 10.2 mg/dL
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)	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.
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)	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.
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)	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.
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)	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.
Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase	Weeks 22-26	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	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.
Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase	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.
Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase	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.
Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase	Weeks 22-26	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	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.
Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12	Weeks 48-52	Hypercalcemia is defined as at least one corrected serum calcium value \>= 10.2 mg/dL
Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase	Weeks 22-26	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	Weeks 22-26	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	Weeks 22-26	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	Weeks 22-26	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	Weeks 22-26	Hyperphosphatemia is defined as at least one serum phosphorus value \>= 5.5 mg/dL
Subject Incidence of Hyperphosphatemia During the Maintenance Phase	Weeks 26-48	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	Weeks 48-52	Hyperphosphatemia is defined as at least one serum phosphorus value \>= 5.5 mg/dL