Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients

NCT ID: NCT02338934

Last Updated: 2015-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Secondary Hyperparathyroidism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cinacalcet with Vitamin D arm

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.

Group Type: EXPERIMENTAL

Combination Cinacalcet with Vitamin D analogue

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role: collaborator

Penang Hospital, Malaysia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr.Ong Loke Meng

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ong Loke Meng, FRCS

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Centre, Penang Hospital, Malaysia

Locations

Clinical Research Centre, Penang Hospital

George Town, Pulau Pinang, Malaysia

Penang Hospital

George Town, Pulau Pinang, Malaysia

Countries

Malaysia

Central Contacts

Ong Loke Meng, FRCS

Role: CONTACT

onglm@crc.gov.my

00 604 2225333 ext. 767

Facility Contacts

Ong Loke Meng, FRCS

Role: primary

onglm@crc.gov.my

00 604 2225333 ext. 767

Other Identifiers

CT14-HPP-004

Identifier Type: -

Identifier Source: org_study_id