Intravenous Paricalcitol in Chronic Hemodialysis Patients

NCT03023748 | Unknown Phase 4 DMC

• 1 other identifier: UW11-293
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Endstage Renal Disease; Secondary Hyperparathyroidism

Keywords

activated vitamin D treatment

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular mass index

  MRI determined cardiac parameters

  52 weeks and 104 weeks

Secondary Outcomes (7)

• Change in Coronary artery calcium score

  52 and 104 weeks

• Change in Aortic stiffness

  52 and 104 weeks

• Change in handgrip strength

  52 and 104 weeks

• Change in Serum albumin

  52 and 104 weeks

• Change in serum Calcium and phosphate

  52 and 104 weeks

Study Arms (1)

intravenous paricalcitol solutions

EXPERIMENTAL

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

Interventions

Intravenous Paricalcitol DRUG

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

Also known as: Zemplar

intravenous paricalcitol solutions

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with metastatic malignancy,
• Patients with extremely poor general condition (eg. bedbound) and expected lifespan is below 6 months

Sponsors & Collaborators

• The University of Hong Kong: lead
• AbbVie: collaborator

Study Sites (1)

Queen Mary Hospital and Tung Wah Hospital

Hong Kong, Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Angela YM Wang, MD PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Associate Professor

Study Record Dates

• First Submitted: January 7, 2017
• First Posted: January 18, 2017
• Study Start: September 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)