Intravenous Paricalcitol in Chronic Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Endstage Renal Disease, Secondary Hyperparathyroidism

Intervention / Treatment
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* Drug: Intravenous Paricalcitol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous paricalcitol solutions<br>Intravenous paricalcitol will be administered twice or thrice weekly post-hemodialysis with a dose based on the baseline iPTH level divided by 120. For instance, with a baseline iPTH 1200pg/mL, an induction dose of 10mcg twice or thrice weekly will be given. The maximum weekly dose allowed is 30mcg. Subsequent dose titration may be required depending on the serum PTH level. Intravenous paricalcitol will be continued up to 24 months. | Drug: Intravenous Paricalcitol<br>* Twenty four months of intravenous paricalcitol will be given twice or thrice weekly post-hemodialysis depending on frequency of hemodialysis of the patients<br>* Other names: Zemplar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricular mass index | MRI determined cardiac parameters | 52 weeks and 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Coronary artery calcium score | Computed tomography determined coronary artery calcium score | 52 and 104 weeks | 
| Change in Aortic stiffness | aortic pulse wave velocity | 52 and 104 weeks | 
| Change in handgrip strength | nutrition and functional parameters | 52 and 104 weeks | 
| Change in Serum albumin | Nutrition parameters | 52 and 104 weeks | 
| Change in serum Calcium and phosphate | Biochemical parameters of CKD-MBD | 52 and 104 weeks | 
| Change in Intact parathyroid hormone | Biochemical parameters of CKD-MBD | 52 and 104 weeks | 
| Change in alkaline phosphatase | biochemical parameters of CKD-MBD | 52 and 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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activated vitamin D treatment