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Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients

NCT02338934 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-01-14

No results posted yet for this study

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

Conditions

  • Secondary Hyperparathyroidism

Interventions

DRUG

Combination Cinacalcet with Vitamin D analogue

Depending on the iPTH level and the serum calcium level they will be started on Cinacalcet 25mg OD and active Vitamin D will be adjusted. If Serum Cal \<2.4 mmol/L - Start Cinacalcet 25mg OD \& Increase active Vit D by 1 mcg/dose 3x/week Increase active Vit D by 1 mcg/dose 3x/week or Serum Ca 2.4-2.54 mmol/L- Start Cinacalcet 25mg OD and Maintain active Vit D dose OR if \>2.54 mmol/L - Start Cinacalcet 25mg OD \& Maintain active Vit D dose. Then they will go to maintenance phase.

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    collaborator OTHER_GOV

  • Penang Hospital, Malaysia

    lead OTHER_GOV

Principal Investigators

  • Ong Loke Meng, FRCS · Clinical Research Centre, Penang Hospital, Malaysia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02338934 on ClinicalTrials.gov