Overview

Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients

Status:
Unknown status

Trial end date:
2017-01-01

Target enrollment:
0

Participant gender:
All

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

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Penang Hospital, Malaysia

Collaborator:

Ministry of Health, Malaysia

Treatments:

Cinacalcet
Cinacalcet Hydrochloride
Ergocalciferols
Vitamin D
Vitamins

Criteria

Inclusion Criteria:1. End Stage Renal Failure (ESRF) patients on haemodialysis with iPTH
levels more than 9x upper limit normal 2. Patients who has history of active Vitamin D
analogue doses limited by hypercalcaemia (>2.54 mmol/L)

Exclusion Criteria:

1. Pregnant or breastfeeding or planning to become pregnant

2. Life expectancy of 6 months or less

3. History of decompensated liver disease