Cinacalcet 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.
ID
Bron
Verkorte titel
Aandoening
open label observational study during 8 months in approx 20 renal transplant patients
Ondersteuning
Academic Medical Center
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Normalisation of serum calcium and parathormon at six months.
Achtergrond van het onderzoek
Calcimimetics 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.
Doel van het onderzoek
Cinacalcet 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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
P.O. Box 22660
S. Surachno
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664170 / +31 (0)20 5669111
s.surachno@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
S. Surachno
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664170 / +31 (0)20 5669111
s.surachno@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Antirejection therapy less than 4 weeks; prior to inclusion;
2. Pregnancy.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL538 |
| NTR-old | NTR582 |
| Ander register | : N/A |
| ISRCTN | NO ISRCTN (not randomized) |