Chronic Renal Insufficiency, Secondary Hyperparathyroidism
Conditions
Brief summary
This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.
Interventions
DRUGcinacalcet (AMG 073)
Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have chronic renal insufficiency (pre-dialysis) * Have below normal creatinine clearance * Have elevated parathyroid hormone levels
Exclusion criteria
* Pregnant or nursing * Heart attack in the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase | Efficacy assessment phase (weeks 12-18) | Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase | Baseline, efficacy assessment phase (weeks 12-18) | Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase |
Participant flow
Recruitment details
Participants were enrolled from 28 June 2002 through 14 November 2002
Participants by arm
| Arm | Count |
|---|---|
| Cinacalcet (AMG 073) Cinacalcet administered orally once daily with dose titrated starting at 30 mg | 27 |
| Placebo Placebo administered orally once daily | 27 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Ineligibility determined | 1 | 0 |
| Overall Study | Initiation of maintenance dialysis | 1 | 1 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Cinacalcet (AMG 073) | Placebo | Total |
|---|---|---|---|
| Age Continuous | 60.6 Years STANDARD_DEVIATION 15.5 | 61.9 Years STANDARD_DEVIATION 15.2 | 61.2 Years STANDARD_DEVIATION 15.2 |
| Glomerular Filtration Rate (GFR) Stratification Factor GFR ≥ 15 and < 25 ml/min/1.73 m^2 | 20 Participants | 19 Participants | 39 Participants |
| Glomerular Filtration Rate (GFR) Stratification Factor GFR ≥ 25 and ≤ 50 ml/min/1.73 m^2 | 7 Participants | 8 Participants | 15 Participants |
| Intact Parathyroid Hormone (iPTH) | 243.3 pg/mL STANDARD_DEVIATION 139.5 | 236.1 pg/mL STANDARD_DEVIATION 189.5 | 239.7 pg/mL STANDARD_DEVIATION 164.9 |
| Race/Ethnicity, Customized Black | 6 Participants | 10 Participants | 16 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 13 Participants | 31 Participants |
| Sex: Female, Male Female | 11 Participants | 5 Participants | 16 Participants |
| Sex: Female, Male Male | 16 Participants | 22 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 27 | 25 / 27 |
| serious Total, serious adverse events | 6 / 27 | 3 / 27 |
Outcome results
Primary
Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase
Time frame: Efficacy assessment phase (weeks 12-18)
Population: All randomized participants, using Last Value Carried Forward (LVCF) imputation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet (AMG 073) | Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase | 15 Participants |
| Placebo | Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase | 5 Participants |
p-value: 0.00695% CI: [1.6, 20.06]Cochran-Mantel-Haenszel
Secondary
Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase
Time frame: Baseline, efficacy assessment phase (weeks 12-18)
Population: All randomized participants, using Last Value Carried Forward (LVCF) imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cinacalcet (AMG 073) | Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase | -31.5 Percent change | Standard Error 6.7 |
| Placebo | Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase | 5.8 Percent change | Standard Error 6.97 |
p-value: <0.001ANCOVA