Intravenous Paricalcitol in Chronic Hemodialysis Patients

• ClinicalTrials.gov Identifier: NCT03023748
• Recruitment Status: Unknown
• First Posted: January 18, 2017
• Last Update Posted: January 18, 2017
• Sponsor: The University of Hong Kong
• Collaborator: AbbVie
• Information provided by (Responsible Party): Dr. Angela Yee-Moon Wang, The University of Hong Kong

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Hong Kong

Queen Mary Hospital and Tung Wah Hospital

Hong Kong, Hong Kong, 0000

Sponsors and Collaborators

The University of Hong Kong

AbbVie

Investigators

• Principal Investigator: Angela YM Wang, MD PhD; The University of Hong Kong

More Information

• 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
• 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:

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