Chronic Kidney Disease Clinical Trial
Official title:
Treatment of Secondary Hyperparathyroidism in the Uremic Patient. A Study Comparing Alfacalcidol and Paricalcitol
The purpose of this study is to compare alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients.
Secondary hyperparathyroidism is a common feature in patients with chronic kidney disease.
Its clinical consequences include renal osteodystrophy, calciphylaxia and potentially
vascular calcifications with increased morbidity and mortality.
Reduced synthesis of active vitamin D contributes to secondary hyperparathyroidism.
Therefore we primarily manage this condition with activated vitamin D. In Denmark
alfacalcidol is the primary choice of vitamin D analog.
However hypercalcemia and hyperphosphatemia may limit the use of alfacalcidol therapy due to
increased risk of vascular calcification and mortality.
Therefore a new vitamin D analog, paricalcitol, has been developed, that may be less prone
to develop hypercalcemia and hyperphosphatemia.
However a randomised controlled clinical study comparing alfacalcidol and paricalcitol has
never been performed.
The primary objective of this study is to evaluate the effect of alfacalcidol and
paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia
and hypercalcemia.
The study is performed in 117 patients with end stage renal failure on maintenance
hemodialysis therapy in 6 different Danish hemodialysis units.
The design is a multicenter crossover study where patients are randomized into two treatment
arms. After a wash out period of 6 weeks they are receiving alfacalcidol or paricalcitol for
a period of 16 weeks and after a further wash out period of 6 weeks they receive the
contrary treatment (respectively paricalcitol or alfacalcidol) for 16 weeks.
The initial dose of alfacalcidol (1 μg intravenously after dialysis) and paricalcitol (3 μg
intravenously after dialysis) will be adjusted every second week based on iPTH, p-calcium
and p-phosphate.
P-calcium, p-phosphate, iPTH, pulse and blood pressure are measured every second week. By
the beginning and the end of each period of treatment, alkaline phosphatase, 25OH-D3, 1,25
(OH)2 vitamin D and safety parameters are measured, pulse wave velocity and pulse wave
analysis is performed in a subgroup.
Alfacalcidol and paricalcitol are both registered treatment modalities for patients with
renal failure and secondary hyperparathyroidism and should not perform any risk for the
safety of the enrolled patients as well as the blood sampling and blood pressure measurement
should not perform any risk either.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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