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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

Tracking Information
First Submitted Date  ICMJE January 7, 2017
First Posted Date  ICMJE January 18, 2017
Last Update Posted Date January 18, 2017
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2017)
Change in left ventricular mass index [ Time Frame: 52 weeks and 104 weeks ]
MRI determined cardiac parameters
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2017)
  • Change in Coronary artery calcium score [ Time Frame: 52 and 104 weeks ]
    Computed tomography determined coronary artery calcium score
  • Change in Aortic stiffness [ Time Frame: 52 and 104 weeks ]
    aortic pulse wave velocity
  • Change in handgrip strength [ Time Frame: 52 and 104 weeks ]
    nutrition and functional parameters
  • Change in Serum albumin [ Time Frame: 52 and 104 weeks ]
    Nutrition parameters
  • Change in serum Calcium and phosphate [ Time Frame: 52 and 104 weeks ]
    Biochemical parameters of CKD-MBD
  • Change in Intact parathyroid hormone [ Time Frame: 52 and 104 weeks ]
    Biochemical parameters of CKD-MBD
  • Change in alkaline phosphatase [ Time Frame: 52 and 104 weeks ]
    biochemical parameters of CKD-MBD
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Paricalcitol in Chronic Hemodialysis Patients
Official Title  ICMJE Providing Intravenous Paricalcitol Treatment to the Sick and Poor Chronic Hemodialysis Patients With Severe Secondary Hyperparathyroidism Resistant to Existing Vitamin D Analogs
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endstage Renal Disease
  • Secondary Hyperparathyroidism
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Drug: Intravenous Paricalcitol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 14, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03023748
Other Study ID Numbers  ICMJE UW11-293
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Angela Yee-Moon Wang, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE AbbVie
Investigators  ICMJE
Principal Investigator: Angela YM Wang, MD PhD The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP