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

Seoul National University Hospital66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Hyperparathyroidism

Interventions

cinacalcetDRUG

cinacalcet 25mg qd or 50 mg qd

controlDRUG

vit D + P binder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (7)

Seoul National University Hospital

Seoul, Korea, South Korea

Kyungpook National University

Daegu, South Korea

Gil Hospital

Incheon, South Korea

Hallym University Sacred Hospital

Pyungchon, South Korea

Outcomes

Primary Outcomes

> 30% reduction from baseline of intact parathyroid hormone (iPTH)

Time frame: 20 weeks

Secondary Outcomes

Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml)

Time frame: 20 weeks

Achievement of targets for mean Ca x P (<55 mg2/dL2), Ca (<9.5 mg/dL), P (<5.5 mg/dL)

Time frame: 20 weeks

Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously

Time frame: 20 weeks

Vascular calcification score

Abdominal aortic calcification score (AAC, 0-24) will be measured at baseline and at 20 weeks according to Kauppila et al (Atherosclerosis 2004)

Time frame: 20 weeks

Normalization of serum alkaline phosphatase

Serum alkaline phosphatase measured at baseline and 20 weeks

Time frame: 20 weeks

Serum FGF-23

Elevated serum levels of fibroblast growth factor-23 (FGF23) is associated with adverse outcomes in dialyzed patients. Therefore, we added analysis of change in FGF23 levels between two treatments to explore the cinacalcet effect in lowering FGF23.

Time frame: baseline and 20th week

Data from ClinicalTrials.gov

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