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
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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Change in left ventricular mass index [ Time Frame: 52 weeks and 104 weeks ]MRI determined cardiac parameters
- 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
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
|Queen Mary Hospital and Tung Wah Hospital|
|Hong Kong, Hong Kong, 0000|
|Principal Investigator:||Angela YM Wang, MD PhD||The University of Hong Kong|