Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03023748
Study type Interventional
Source The University of Hong Kong
Contact
Status Active, not recruiting
Phase Phase 4
Start date September 2011
Completion date January 2018

See also
  Status Clinical Trial Phase
Completed NCT02549417 - Phase 3 Study of KHK7580 Phase 3
Completed NCT02549404 - Phase 3 Study of KHK7580 Phase 3
Not yet recruiting NCT02536287 - Comparison of Total Parathyroidectomy With and Without Autotransplantation Phase 3
Completed NCT02549391 - Phase 3 Study of KHK7580 Phase 2/Phase 3
Withdrawn NCT01426724 - Effects of Vitamin D on Renal Blood Flow, Proteinuria and Inflammation in Patients With Chronic Kidney Disease N/A
Completed NCT01101113 - Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level Phase 4
Completed NCT01220050 - Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism Phase 2
Completed NCT00537979 - Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis Phase 4
Completed NCT00379899 - ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis Phase 4
Completed NCT00431496 - A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD) Phase 4
Completed NCT00073710 - Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium Phase 4
Completed NCT00117052 - SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism Phase 3
Completed NCT03626948 - SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis Phase 3
Completed NCT01382212 - A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis Phase 3
Completed NCT01219855 - Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT) Phase 2/Phase 3
Completed NCT01224782 - Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT) N/A
Completed NCT00990704 - Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism Phase 2
Completed NCT00999037 - FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease N/A
Completed NCT00742716 - Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease Phase 2
Recruiting NCT06126016 - A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.