Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients

• ClinicalTrials.gov Identifier: NCT02338934
• Recruitment Status: Unknown
• First Posted: January 14, 2015
• Last Update Posted: January 14, 2015
• Sponsor: Penang Hospital, Malaysia
• Collaborator: Ministry of Health, Malaysia
• Information provided by (Responsible Party): Dr.Ong Loke Meng, Penang Hospital, Malaysia

Tracking Information

• First Submitted Date: January 11, 2015
• First Posted Date: January 14, 2015
• Last Update Posted Date: January 14, 2015
• Study Start Date: January 2015
• Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 13, 2015): Percentage reduction of iPTH levels from baseline at 6 months treatment [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 13, 2015)

• 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 ]
• The maximum iPTH reduction from baseline [ Time Frame: 24 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Secondary Hyperparathyroidism

Intervention

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.

Study Arms

Experimental: 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.

Intervention: Drug: Combination Cinacalcet with Vitamin D analogue

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 13, 2015): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2017
• Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

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:

1. Pregnant or breastfeeding or planning to become pregnant
2. Life expectancy of 6 months or less
3. History of decompensated liver disease

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Malaysia

Administrative Information

• NCT Number: NCT02338934
• Other Study ID Numbers: CT14-HPP-004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr.Ong Loke Meng, Penang Hospital, Malaysia
• Study Sponsor: Penang Hospital, Malaysia
• Collaborators: Ministry of Health, Malaysia

Investigators

• Principal Investigator: Ong Loke Meng, FRCS; Clinical Research Centre, Penang Hospital, Malaysia

• PRS Account: Penang Hospital, Malaysia
• Verification Date: January 2015