Neoplasms

Symptoms and General Pathology

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

Bone Density Conservation Agents

All Drugs and Chemicals

Micronutrients

Alfacalcidol

Hydroxycholecalciferols

Vitamins

Trace Elements

A: oral daily alfacalcidol treatments total 6 microgram/week

B: pulse (trice a week) alfacalcidol treatments total 6 microgram/week

Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective was to observe the adverse effects between these two treatment regimens.

ESRD patients with secondary hyperparathyroidism in 3 hemodialysis centers were enrolled. They were assigned to either oral daily or pulse (trice a week) alfacalcidol treatments using block-of-4 randomization. Alfacalcidol in both groups were equal at the dose of 6 microgram per week. Clinical and laboratory data were obtained at baseline and were monitored every 4 weeks for 12 weeks. Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test. All possible adverse events were carefully monitored.

Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.

Effectiveness Between Daily Versus Pulse Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients: A Randomized Controlled Trial and Multicenter Study

mean PTH reduction between two groups at the end of the study by unpaired-T test.

Phramongkutklao College of Medicine and Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nutritional and Metabolic Diseases

Kidney Diseases

Renal Insufficiency, Chronic

Kidney Failure, Chronic

Renal Insufficiency

Vitamin D Deficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Vitamin D

Cholecalciferol

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

alfacalcidol 16 weeks, 6 weeks wash out, paricalcitol 16 weeks

paricalcitol ´16 weeks, 6 weeks wash out, alfacalcidol 16 weeks

3 microg 3 times a week. dosage is increased/decreased 50 % every second week according to iPTH, ionised s-calcium and phosphate

paricalcitol

1 microg 3 times a week, dosage is titrated every second week according to iPTH, phosphate and ionised s-calcium.

alfacalcidol

Ditte Hansen, MD

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.

Treatment of Secondary Hyperparathyroidism in the Uremic Patient

Treatment of Secondary Hyperparathyroidism in the Uremic Patient. A Study Comparing Alfacalcidol and Paricalcitol

Zealand University Hospital

Ditte Hansen MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.	NCT02895061	Alfacalcidol, S...	Alfacalcidol	18 Years -	Phramongkutklao College of Medicine and Hospital
Treatment of Secondary Hyperparathyroidism in the Uremic Patient	NCT00469599	Secondary Hyper... Chronic Kidney ... Vitamin D Defic...	paricalcitol alfacalcidol	18 Years -	Zealand University Hospital
Treatment of Secondary Hyperparathyroidism in the Uremic Patient	NCT00469599	Secondary Hyper... Chronic Kidney ... Vitamin D Defic...	paricalcitol alfacalcidol	18 Years -	Zealand University Hospital
Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.	NCT02895061	Alfacalcidol, S...	Alfacalcidol	18 Years -	Phramongkutklao College of Medicine and Hospital

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