Clinical trial NCT03023748: Intravenous Paricalcitol in Chronic Hemodialysis Patients
Official title: Providing Intravenous Paricalcitol Treatment to the Sick and Poor Chronic Hemodialysis Patients With Severe Secondary Hyperparathyroidism Resistant to Existing Vitamin D Analogs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endstage Renal Disease
Secondary Hyperparathyroidism
Keywords: activated vitamin D treatment
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2017-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in left ventricular mass index
timeFrame: 52 weeks and 104 weeks
Secondary outcomes:
measure: Change in Coronary artery calcium score
timeFrame: 52 and 104 weeks
measure: Change in Aortic stiffness
timeFrame: 52 and 104 weeks
measure: Change in handgrip strength
timeFrame: 52 and 104 weeks
measure: Change in Serum albumin
timeFrame: 52 and 104 weeks
measure: Change in serum Calcium and phosphate
timeFrame: 52 and 104 weeks
measure: Change in Intact parathyroid hormone
timeFrame: 52 and 104 weeks
measure: Change in alkaline phosphatase
timeFrame: 52 and 104 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital and Tung Wah Hospital
Study officials:
affiliation: The University of Hong Kong
name: Angela YM Wang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: