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Intravenous Paricalcitol in Chronic Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT03023748
Recruitment Status : Unknown
Verified January 2017 by Dr. Angela Yee-Moon Wang, The University of Hong Kong.
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Dr. Angela Yee-Moon Wang, The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Endstage Renal Disease Secondary Hyperparathyroidism Drug: Intravenous Paricalcitol Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Vitamin D

Arm Intervention/treatment
Experimental: intravenous paricalcitol solutions

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
Twenty four months of intravenous paricalcitol will be given twice or thrice weekly post-hemodialysis depending on frequency of hemodialysis of the patients
Other Name: Zemplar




Primary Outcome Measures :
  1. Change in left ventricular mass index [ Time Frame: 52 weeks and 104 weeks ]
    MRI determined cardiac parameters


Secondary Outcome Measures :
  1. Change in Coronary artery calcium score [ Time Frame: 52 and 104 weeks ]
    Computed tomography determined coronary artery calcium score

  2. Change in Aortic stiffness [ Time Frame: 52 and 104 weeks ]
    aortic pulse wave velocity

  3. Change in handgrip strength [ Time Frame: 52 and 104 weeks ]
    nutrition and functional parameters

  4. Change in Serum albumin [ Time Frame: 52 and 104 weeks ]
    Nutrition parameters

  5. Change in serum Calcium and phosphate [ Time Frame: 52 and 104 weeks ]
    Biochemical parameters of CKD-MBD

  6. Change in Intact parathyroid hormone [ Time Frame: 52 and 104 weeks ]
    Biochemical parameters of CKD-MBD

  7. Change in alkaline phosphatase [ Time Frame: 52 and 104 weeks ]
    biochemical parameters of CKD-MBD



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023748


Locations
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Hong Kong
Queen Mary Hospital and Tung Wah Hospital
Hong Kong, Hong Kong, 0000
Sponsors and Collaborators
The University of Hong Kong
AbbVie
Investigators
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Principal Investigator: Angela YM Wang, MD PhD The University of Hong Kong

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Responsible Party: Dr. Angela Yee-Moon Wang, Honorary Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03023748     History of Changes
Other Study ID Numbers: UW11-293
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Angela Yee-Moon Wang, The University of Hong Kong:
activated vitamin D treatment
Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Failure, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Kidney Diseases
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents