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Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients

Primary Purpose

Secondary Hyperparathyroidism

Status
Unknown status
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
Combination Cinacalcet with Vitamin D analogue
Sponsored by
Penang Hospital, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Centre, Penang Hospital
  • Penang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cinacalcet with Vitamin D arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage reduction of iPTH levels from baseline at 6 months treatment

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2015
Last Updated
January 13, 2015
Sponsor
Penang Hospital, Malaysia
Collaborators
Ministry of Health, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT02338934
Brief Title
Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients
Official Title
An Open-label Study of Combination of Cinacalcet and Active Vitamin D Analogue in the Management of Severe Secondary Hyperparathyroidism in Haemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penang Hospital, Malaysia
Collaborators
Ministry of Health, Malaysia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Many patients on haemodialysis will develop secondary hyperparathyroidism. Vitamin D analogues such as alphacalcidol are needed to bring their iPTH levels down to normal. However, these analogues can cause hypercalcaemia, thus its doses are limited by this effect. Cinacalcet, which is currently not widely available to patients in hospitals, is a calcimimetic that can reduce both iPTH and serum calcium levels. No studies have yet to be carried out investigating the outcome of using low doses of Cinacalcet as a means of optimizing doses of vitamin D analogues by keeping calcium levels from going over the upper limit. So a single arm, open-labelled study has been designed to determine the effectiveness of combination Cinacalcet with Vitamin D analogue in the treatment of severe hyperparathyroidism in patients with ESRF on haemodialysis. No formal sample size calculation was done as this is a proof of concept study. Power calculation will be done at the end based on the primary outcome of the study. Methodology: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cinacalcet with Vitamin D arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Combination Cinacalcet with Vitamin D analogue
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage reduction of iPTH levels from baseline at 6 months treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit normal at 6, 12 and 24 months
Time Frame
24 months
Title
The maximum iPTH reduction from baseline
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Pregnant or breastfeeding or planning to become pregnant Life expectancy of 6 months or less History of decompensated liver disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ong Loke Meng, FRCS
Phone
00 604 2225333
Ext
767
Email
onglm@crc.gov.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ong Loke Meng, FRCS
Organizational Affiliation
Clinical Research Centre, Penang Hospital, Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Centre, Penang Hospital
City
George Town
State/Province
Penang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Penang Hospital
City
George Town
State/Province
Penang
ZIP/Postal Code
10990
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ong Loke Meng, FRCS
Phone
00 604 2225333
Ext
767
Email
onglm@crc.gov.my

12. IPD Sharing Statement

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Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients

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