NCT02338934

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

January 11, 2015

Last Update Submit

January 13, 2015

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (2)

  • Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit normal at 6, 12 and 24 months

    24 months

  • The maximum iPTH reduction from baseline

    24 months

Study Arms (1)

Cinacalcet with Vitamin D arm

EXPERIMENTAL

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.

Drug: Combination Cinacalcet with Vitamin D analogue

Interventions

Combination Cinacalcet with Vitamin D analogueDRUG

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.

Cinacalcet with Vitamin D arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Pregnant or breastfeeding or planning to become pregnant
  • Life expectancy of 6 months or less
  • History of decompensated liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Research Centre, Penang Hospital

George Town, Pulau Pinang, 10990, Malaysia

Location

Penang Hospital

George Town, Pulau Pinang, 10990, Malaysia

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Ong Loke Meng, FRCS

    Clinical Research Centre, Penang Hospital, Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ong Loke Meng, FRCS

CONTACT

00 604 2225333onglm@crc.gov.my

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 11, 2015

First Posted

January 14, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

MY(2)