No registrations found.
ID
Source
Brief title
Health condition
open label observational study during 8 months in approx 20 renal transplant patients
Sponsors and support
Academic Medical Center
Intervention
Outcome measures
Primary outcome
Normalisation of serum calcium and parathormon at six months.
Secondary outcome
Reduced and sustained parathormon activity after withdrawal of cinacalcet.
Background summary
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.
Study objective
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.
Study design
N/A
Intervention
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.
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
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
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL538 |
| NTR-old | NTR582 |
| Other | : N/A |
| ISRCTN | NO ISRCTN (not randomized) |