Chronic Kidney Disease, Kidney Disease
Conditions
Keywords
Sensipar®, Mimpara®, Cinacalcet, Calcimimetic, Chronic Kidney Disease
Brief summary
The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).
Interventions
DRUGCinacalcet HCl
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Chronic Kidney Disease patients not receiving dialysis with: - An iPTH greater than 100 pg/mL \[10.6 pmol/L\] for subjects with stage 3 CKD or greater than or equal to 160 pg/mL \[17.0 pmol/L\] for subjects with stage 4 CKD; - A serum calcium greater than 9.0 mg/dL \[2.25 mmol/L\]; - An estimated GFR less than or equal to 59 mL/min and greater than or equal to 15 mL/min.
Exclusion criteria
- Have an unstable medical condition, defined as having been hospitalized within 30 days before day 1, or otherwise unstable in the judgment of the investigator. - Experienced a myocardial infarction (MI) within 3 months before day 1. - Likely to initiate dialysis (in the opinion of the investigator) or are scheduled to undergo renal transplantation within 28 weeks after day 1. - Received active vitamin D therapy (i.e., 1-hydroxylated metabolites of vitamin D) for less than 30 days before day 1 or required a change in active vitamin D brand or dose level within 30 days before day 1 (for patients prescribed active vitamin D).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in iPTH at 32 weeks. | — |
| Safety and tolerability of cinacalcet at 32 weeks. | — |
Outcome results
None listed