Efficacy of cinacalcet in hyperparathyroidism after renal transplantation.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR582
• Date of registration: 31/01/2006
• Primary sponsor: Academic Medical Center (AMC), Renal Transplant Unit
• Public title: Efficacy of cinacalcet in hyperparathyroidism after renal transplantation.
• Scientific title: The efficacy of the calcimimetic Cinacalcet in persistent Hyperparathyroidsm After Renal Transplantation. A sustained or temporary effect? - CHART
• Date of first enrolment: 1/2/2006
• Target sample size: 20
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=582
• Study type: intervention
• Study design: Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: Single arm

Countries of recruitment

The Netherlands

Contacts

• Name: S. Surachno

• Name: S. Surachno

Key inclusion & exclusion criteria

Inclusion criteria: 1. Hypercalciemia more than 2,60 mmol/l;

2. Elevated iPTH plasma levels more than 15 pmol/l;

3. Renaltranplantion longer than 2 months and stable renal function for at least 2 weeks;

4. Older than 18 years;

5. No vit D deficiency.
Exclusion criteria: 1. Antirejection therapy less than 4 weeks; prior to inclusion;

2. Pregnancy.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Renal transplant

Intervention(s)

Administration of start dose of 30 mg cinacalcet when inclusion criteria are met.
Weekly and later monthly monitoring of biochemical and clinical parameters.
Six month after inclusion and reaching stable state (normocalciemia) slowly withdrawal of cinacalcet.

Primary Outcome(s)

Normalisation of serum calcium and parathormon at six months.

Secondary Outcome(s)

Reduced and sustained parathormon activity after withdrawal of cinacalcet.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Academic Medical Center (AMC)