Endstage Renal Disease, Secondary Hyperparathyroidism
Conditions
Keywords
activated vitamin D 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.
Interventions
DRUGIntravenous Paricalcitol
Twenty four months of intravenous paricalcitol will be given twice or thrice weekly post-hemodialysis depending on frequency of hemodialysis of the patients
Sponsors
AbbVie
The University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular mass index | 52 weeks and 104 weeks | MRI determined cardiac parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Aortic stiffness | 52 and 104 weeks | aortic pulse wave velocity |
| Change in handgrip strength | 52 and 104 weeks | nutrition and functional parameters |
| Change in Serum albumin | 52 and 104 weeks | Nutrition parameters |
| Change in Coronary artery calcium score | 52 and 104 weeks | Computed tomography determined coronary artery calcium score |
| Change in Intact parathyroid hormone | 52 and 104 weeks | Biochemical parameters of CKD-MBD |
| Change in alkaline phosphatase | 52 and 104 weeks | biochemical parameters of CKD-MBD |
| Change in serum Calcium and phosphate | 52 and 104 weeks | Biochemical parameters of CKD-MBD |
Countries
Hong Kong
Outcome results
None listed