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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: cinacalcet; Drug: control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01101113

CINA-Kor-01

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Cinacalcet

Experimental group

Description:

stepwise dose of cinacalcet + regular medical medication including vit D

Treatment:

Drug: cinacalcet

Control

Active Comparator group

Description:

conventional treatment for secondary HPT including vit D and phosphate binder

Treatment:

Drug: control