Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients
Status:
Unknown status
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
This is a single arm, open-labelled study to determine the effectiveness of combination
Cinacalcet with Vitamin D analogue in the treatment of severe hyperparathyroidism in patients
with ESRF on haemodialysis. Patients will be started on PO Cinacalcet 25mg OD + PO/IV active
Vitamin D analogues adjusted by increments/decrements in steps of 1 mcg 3x per week every 1-4
weeks until the corrected calcium level is within 2.4-2.54 mmol/L. After iPTH has reached
2-9x ULN, patient enters maintenance phase. If serum calcium falls below 2.1mmol/L, active
Vit D dose will be increased and if it is above 2.54 mmol/L, the dose will be decreased.
Percentage reduction of iPTH levels from baseline at 6,12 and 24 months treatment and
Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit
normal at 6, 12 and 24 months will be determined
Phase:
Phase 4
Details
Lead Sponsor:
Penang Hospital, Malaysia
Collaborator:
Ministry of Health, Malaysia
Treatments:
Cinacalcet Cinacalcet Hydrochloride Ergocalciferols Vitamin D Vitamins