Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Jeil-Kirin Pharmaceutical Inc.
• Treatments: Cinacalcet; Cinacalcet Hydrochloride

Criteria

Inclusion Criteria:

• Peritoneal dialysis patients with secondary HPT(iPTH > 300 pg/mL)

• > 18 yr of age, < 70

• had receive PD for > 3 mo,

• intact PTH level > 300 pg/ml and <1000 pg/ml

• albumin corrected Ca level >= 9.0 mg/dL

Exclusion Criteria:

• pregnant or breast-feeding,

• had undergone parathyroidectomy within previous 3 mo,

• are involved in other clinical trial within 30 d

• had received cinacalcet therapy previously.