Secondary Hyperparathyroidism Clinical Trial
Official title:
A PROSPECTIVE, PILOT, CROSS-OVER STUDY TO ASSESS THE EFFICACY OF PARICALCITOL IN REDUCING PARATHYROID HORMONE LEVELS AND AMELIORATING MARKERS OF BONE REMODELLING IN RENAL TRANSPLANT RECIPIENTS WITH SECONDARY HYPERPARATHYROIDISM
The risk of fracture for kidney transplant recipients is 4 times higher that of the general
population. The hyperparathyroidism plays a key role in the maintenance or development of
post-transplant alterations of bone remodelling.
Renal transplant patients are at high risk of hyperparathyroidism, largely because of
long-lasting renal insufficiency before transplant, and of progressive deterioration of
kidney function because of chronic allograft nephropathy (a disease of proteinuria and
progressive decline of the glomerular filtration rate).In hemodialysis patients, intravenous
paricalcitol (19-nor-1,25-dihydroxyvitamin D2), a new vitamin D analogue, achieves a faster
and more effective normalization of parathyroid hormone (PTH) levels than calcitriol
(1,25-dihydroxyvitamin D3), an effect that is associated with smaller changes in serum
calcium and phosphorus levels.
Whether oral paricalcitol may help achieving a prompt reduction in serum PTH levels and,
secondarily, in urinary protein excretion in renal transplant recipients with secondary
hyperparathyroidism is worth investigating.
BACKGROUND The risk of fracture for kidney transplant recipients is 4 times higher that of
the general population. The pathogenesis of post-transplant bone disease is multifactorial,
but hyperparathyroidism plays a key role in the maintenance or development of
post-transplant alterations of bone remodelling. Vitamin D and its analogues are key
components of treatment aimed to prevent or ameliorate secondary hyperparathyroidism in
patients with chronic kidney disease (CKD). In hemodialysis patients, intravenous
paricalcitol (19-nor-1,25-dihydroxyvitamin D2), a new vitamin D analogue, achieves a faster
and more effective normalization of parathyroid hormone (PTH) levels than calcitriol
(1,25-dihydroxyvitamin D3), an effect that is associated with smaller changes in serum
calcium and phosphorus levels. Preliminary evidence is also available that in pre-dialysis
patients with CKD and secondary hyperparathyroidism, treatment with oral paricalcitol may
also reduce urinary protein excretion, an effect that is independent of concomitant
treatment with agents that block the renin-angiotensin system and that in the long-term
might translate into slower progression to end stage kidney disease and need for renal
replacement therapy.
Renal transplant patients are at high risk of hyperparathyroidism, largely because of
long-lasting renal insufficiency before transplant, and of progressive deterioration of
kidney function because of chronic allograft nephropathy (a disease of proteinuria and
progressive decline of the glomerular filtration rate). Whether oral paricalcitol may help
achieving a prompt reduction in serum PTH levels and, secondarily, in urinary protein
excretion in renal transplant recipients with secondary hyperparathyroidism is worth
investigating.
AIMS Primary To evaluate whether 6-months treatment with paricalcitol may achieve a prompt
and effective reduction in PTH serum levels in stable renal transplant patients with
secondary hyperparathyroidism.
DESIGN This will be a Prospective, Randomized, Open label, Cross-over study of 6-months with
Paricalcitol or standard treatment for hyperparathyroidism.
After one month wash-out from any form of Vitamin D therapy, patients satisfying the
inclusion/exclusion criteria will be randomized to two treatment arms:
1. Paricalcitol capsules 1- 2 mcg/day/pts for 26 weeks
2. Standard therapy for hyperparathyroidism for 26 weeks At the end of the first treatment
period with Paricalcitol or Standard therapy each patient will cross-over to the other
treatment.
After baseline evaluation eligible patients will enter a 6 months treatment period whit oral
paricalcitol (1-2 mcg/day), or standard treatment for hyperparathyroidism, added-on
background therapy whit calcium and phosphate supplementation as deemed clinically
appropriate.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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