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Providing Intravenous Paricalcitol Treatment to the Sick and Poor Chronic Hemodialysis Patients With Severe Secondary Hyperparathyroidism Resistant to Existing Vitamin D Analogs (NCT03023748)

AbbVie
This study aims to provide intravenous paritcalcitol treatment for the sick and poor hemodialysis patients with severe secondary hyperparathyroidism (SHPT) resistant to existing vitamin D analogs therapy or with hypercalcemia precluding the use of existing vitamin D analogs. The study aims to evaluate the effect of paricalcitol on control of SHPT, biochemical parameters of chronic kidney disease-mineral bone disease, cardiac parameters, vascular calcification and stiffness parameters and nutrition status in patients receiving chronic hemodialysis treatment.
  • Drug: Intravenous Paricalcitol
    Twenty four months of intravenous paricalcitol will be given twice or thrice weekly post-hemodialysis depending on frequency of hemodialysis of the patients
    • Zemplar
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Chronic hemodialysis patients with severe SHPT (defined as iPTH ≥ 800pg/mL) resistant to rocaltrol or alfacalcidol (defined as iPTH not controlled in the range between 2 - 9 times of lab upper limit reference).
  • Chronic hemodialysis patients with severe SHPT and at the same time hypercalcemia (defined as serum calcium ≥2.56mmol/L) but still < 2.8mmol/L precluding the use of rocaltrol or alfacalcidol but still feasible to use paricalcitol.
Exclusion Criteria:
  • Patients with metastatic malignancy,
  • Patients with extremely poor general condition (eg. bedbound) and expected lifespan is below 6 months
This is a 2-year single-arm intervention study of which intravenous paricalcitol will be provided as a second-line treatment to 30 chronic hemodialysis patients with severe SHPT (defined as intact parathyroid hormone [iPTH] ≥ 800pg/mL) resistant to existing vitamin D analogs treatment (including rocaltrol and alfacalcidol) or with hypercalcemia (defined as serum calcium ≥2.56mmol/L) precluding the use of existing vitamin D analogs.

The study aims to evaluate the control of SHPT, various biochemical parameters of chronic kidney disease-mineral bone disease, left ventricular mass and volumes, vascular calcification and stiffness parameters, handgrip strength and serum albumin with the use of intravenous paricalcitol in patients receiving chronic hemodialysis treatment.

1 locations

Hong Kong (1)
  • Queen Mary Hospital and Tung Wah Hospital
    Not specified
    Hong Kong, Hong Kong, 0000
Status:
active not recruiting
Type:
Interventional
Phase:
Start:
31 August, 2011
Updated:
13 January, 2017
Participants:
30
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