An Open-label Study of Combination of Cinacalcet and Active Vitamin D Analogue in the Management of Severe Secondary Hyperparathyroidism in Haemodialysis Patients

NCT02338934 Phase 4 UNKNOWN

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

Details

Lead sponsor	Penang Hospital, Malaysia
Phase	Phase 4
Status	UNKNOWN
Enrolment	30
Start date	2015-01
Completion	2017-01

Conditions

• Secondary Hyperparathyroidism

Interventions

• Combination Cinacalcet with Vitamin D analogue

Primary outcomes

• Percentage reduction of iPTH levels from baseline at 6 months treatment — 6 months

Countries

Malaysia