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Sponsored by: |
Roskilde County Hospital |
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Information provided by: | Roskilde County Hospital |
ClinicalTrials.gov Identifier: | NCT00469599 |
The purpose of this study is to compare alfalcalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients.
Condition | Intervention |
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Secondary Hyperparathyroidism Chronic Kidney Disease Vitamin D Deficiency |
Drug: paricalcitol Drug: alfacalcidol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Treatment of Secondary Hyperparathyroidism in the Uremic Patient. A Study Comparing Alfacalcidol and Paricalcitol |
Estimated Enrollment: | 117 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
alfalcidol 16 weeks, 6 weeks wash out, paricalcitol 16 weeks
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Drug: paricalcitol
3 mikrog 3 times a week. dosage is increased/decreased 50 % every second week according to iPTH, calcium-ion and phosphate
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2: Active Comparator
paricalcitol ´16 weeks, 6 weeks wash out, alfacalcidol 16 weeks
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Drug: alfacalcidol
1 mikrog 3 times a week, dosage is titrated every second week according to iPTH, phosphate and caklciumion.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ditte Hansen, MD | +45 47 32 19 06 | rsdith@ra.dk |
Contact: Knud Rasmussen, MD DMSc | +45 47 32 20 25 | rskra@ra.dk |
Denmark | |
Viborg County Hospital | Recruiting |
Viborg, Denmark, 8800 | |
Contact: Henning Danielsen, MD | |
Principal Investigator: Henning Danielsen, MD | |
Fredericia County Hospital | Not yet recruiting |
Fredericia, Denmark, 7000 | |
Contact: Kjeld Erik Otte, MD | |
Principal Investigator: Kjeld Erik Otte, MD | |
Aalborg University Hospital | Recruiting |
Aalborg, Denmark, 4000 | |
Contact: Jeppe Christensen, DM,DmSci +45 99321111 | |
Principal Investigator: Jeppe Christensen, SM DMSci | |
Roskilde County Hospital | Recruiting |
Roskilde, Denmark, 4000 | |
Contact: Ditte Hansen, MD | |
Principal Investigator: Ditte Hansen, MD | |
Holbæk County Hospital | Not yet recruiting |
Holbæk, Denmark, 4300 | |
Contact: Niels Løkkegaard, MD | |
Principal Investigator: Niels Løkkegaard, MD | |
Holstebro County Hospital | Not yet recruiting |
Holstebro, Denmark, 7500 | |
Contact: Erling Bjerregaard Pedersen, MD DMSc | |
Principal Investigator: Erling Bjerrregaard Pedersen, MD DMSc | |
Hillerød County Hospital | Recruiting |
Hillerød, Denmark, 3400 | |
Contact: Lisbet Brandi, MD | |
Principal Investigator: Lisbet Brandi, MD |
Principal Investigator: | Ditte Hansen, MD | Roskilde County Hospital |
Responsible Party: | Roskilde County Hospital ( Ditte Hansen MD ) |
Study ID Numbers: | EudraCT 2006-005981-37 |
Study First Received: | May 3, 2007 |
Last Updated: | February 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00469599 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency |
Hyperparathyroidism, Secondary Kidney Failure, Chronic Renal Insufficiency, Chronic |
Vitamin D Deficiency Renal Osteodystrophy Hemodialysis |
Parathyroid Diseases Renal Insufficiency Avitaminosis 1-hydroxycholecalciferol Kidney Failure, Chronic Bone Density Conservation Agents Hyperparathyroidism, Secondary Malnutrition Urologic Diseases Vitamins Neoplasm Metastasis Nutrition Disorders Kidney Diseases |
Micronutrients Deficiency Diseases Vitamin D Deficiency Renal Osteodystrophy Endocrine System Diseases Trace Elements Hydroxycholecalciferols Calcium, Dietary Vitamin D Hyperparathyroidism Renal Insufficiency, Chronic Endocrinopathy Kidney Failure |
Parathyroid Diseases Renal Insufficiency Avitaminosis 1-hydroxycholecalciferol Physiological Effects of Drugs Kidney Failure, Chronic Bone Density Conservation Agents Neoplastic Processes Hyperparathyroidism, Secondary Pathologic Processes Malnutrition Urologic Diseases Vitamins Neoplasm Metastasis |
Nutrition Disorders Kidney Diseases Micronutrients Deficiency Diseases Vitamin D Deficiency Growth Substances Endocrine System Diseases Pharmacologic Actions Hydroxycholecalciferols Neoplasms Hyperparathyroidism Renal Insufficiency, Chronic Kidney Failure |