Treatment of Secondary Hyperparathyroidism in the Uremic Patient
Chronic Kidney Disease
Vitamin D Deficiency
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Secondary Hyperparathyroidism in the Uremic Patient. A Study Comparing Alfacalcidol and Paricalcitol|
- The effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- alkaline phosphatase, 25OH-vitamin D,1,25 OH2-vitamin D,calcium x phosphate product, blood pressure, pulse, pulse pressure, parathyroidectomy, pulse wave velocity and pulse wave analysis, initiation of treatment with calcimimetics. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Study Completion Date:||October 2010|
|Estimated Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
alfacalcidol 16 weeks, 6 weeks wash out, paricalcitol 16 weeks
3 microg 3 times a week. dosage is increased/decreased 50 % every second week according to iPTH, ionised s-calcium and phosphate
Other Name: Zemplar
Active Comparator: 2
paricalcitol ´16 weeks, 6 weeks wash out, alfacalcidol 16 weeks
1 microg 3 times a week, dosage is titrated every second week according to iPTH, phosphate and ionised s-calcium.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469599
|Aalborg University Hospital|
|Aalborg, Denmark, 4000|
|Århus University Hospital Skejby|
|Aarhus, Denmark, 4000|
|Hospital of Southwest Denmark Esbjerg|
|Esbjerg, Denmark, 6700|
|Holbæk County Hospital|
|Holbæk, Denmark, 4300|
|Holstebro County Hospital|
|Holstebro, Denmark, 7500|
|Odense University Hospital|
|Odense, Denmark, 5000|
|Roskilde County Hospital|
|Roskilde, Denmark, 4000|
|Viborg County Hospital|
|Viborg, Denmark, 8800|
|Principal Investigator:||Ditte Hansen, MD||Roskilde County Hospital|