Secondary hyperparathyroidism (HPT) in subjects with chronic kidney disease (CKD) receiving hemodialysis. MedDRA version: 8.1 Level: LLT Classification code 10020708 Term: Hyperparathyroidism secondary
Conditions
Interventions
Trade Name: Mimpara
Product Name: Mimpara
Product Code: AMG 073
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: cinacalcet
CAS Number: 364782-24-3
Current Sponsor code: AMG 073
Concentrat
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults = 18 years on hemodialysis for = 3 months before study day 1 • Intact PTH > 300 pg/ mL ( 31.8 pmol/ L); or bio- intact PTH > 160 pg/ mL ( 17.0 pmol/ L) OR, • iPTH = 150 and = 300 pg/ mL (15.9- 31.8 pmol/L); or bio- intact 80 - 160 pg/mL (8.5 - 17.0 pmol/L), • and subject is receiving active vitamin D therapy, • and corrected serum Ca x P > 50 mg2/ dL2 (3.9 mmol2/L2) • Corrected serum calcium = 8.4 mg/dl (2.1 mmol/L) • Screening CAC score = 30 • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Received non- calcium containing phosphate binders (sevelamer HCl, aluminum-containing phosphate binders, or lanthanum chloride) within 30 days prior to screening • Received cinacalcet within 30 days prior to screening • Current or previous use of bisphosphonates • Started or required a change in HMG CoA reductase inhibitor dose (or other cholesterol- lowering medications) within 30 days before screening • Active atrial fibrillation, history of coronary artery bypass grafting (CABG), history of coronary artery stents, aortic/cardiac valve replacement, cardiac transplant, biventricular leads, thoracic aortic aneurysm • Parathyroidectomy = 3 months before entering screening • Anticipated parathyroidectomy within 6 months after randomization • Specified scheduled date for kidney transplant surgery • Subject exceeds the weight limit of the CT scanner • Subject is pregnant (e.g. 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 randomization) • 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 Day 1 have passed since subject received other investigational agent(s) (devices or drug).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Attenuation of the progression of coronary artery calcification (CAC) in hemodialysis subjects receiving a treatment regimen including cinacalcet and low dose vitamin D.;Secondary Objective: • Attenuation of the progression of aortic calcification. • Attenuation of the progression of aortic valve calcification. • Proportion of subjects achieving > 15% progression of CAC. • Absolute and percent changes in PTH, calcium (Ca), phosphorus (P) and Ca x P. • Safety and tolerability of cinacalcet.;Primary end point(s): Percent change from baseline in CAC score at week 52 | — |
Countries
Finland, Germany, Hungary, Italy, Portugal
Outcome results
None listed