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Efficacy of cinacalcet in hyperparathyroidism after renal transplantation.


- candidate number1956
- NTR NumberNTR582
- ISRCTNNO ISRCTN (not randomized)
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jan-2006
- Secondary IDsN/A 
- Public TitleEfficacy of cinacalcet in hyperparathyroidism after renal transplantation.
- Scientific TitleThe efficacy of the calcimimetic Cinacalcet in persistent Hyperparathyroidsm After Renal Transplantation. A sustained or temporary effect?
- ACRONYMCHART
- hypothesisCinacalcet is able to control hypercalciemia due to hyperparathyreoidism after renal transplantation ergo avoiding surgical removal of parathyroidtissue without jeopardizing renal function or eliciting serious adverse events.
- Healt Condition(s) or Problem(s) studiedRenal transplant
- Inclusion criteria1. 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 criteria1. Antirejection therapy less than 4 weeks; prior to inclusion;
2. Pregnancy.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2006
- planned closingdate1-feb-2007
- Target number of participants20
- InterventionsAdministration 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 outcomeNormalisation of serum calcium and parathormon at six months.
- Secondary outcomeReduced and sustained parathormon activity after withdrawal of cinacalcet.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES S. Surachno
- CONTACT for SCIENTIFIC QUERIES S. Surachno
- Sponsor/Initiator Academic Medical Center (AMC), Renal Transplant Unit
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryCalcimimetics are yet not used extensively after renal transplantation. By this observational open label study we are interested whether cinacalcet is able to normalize hyperparathyroidsm and accompanying hypercalcemia and to which extent this effect is permanent or just temporary.
- Main changes (audit trail)
- RECORD31-jan-2006 - 16-nov-2009


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