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

Phase 4

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: cinacalcet; Drug: control

• Registration Number: NCT01101113
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-04
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Study Start: 2010-09
• Primary Completion: 2012-03
• Status Verified: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cinacalcet	cinacalcet	stepwise dose of cinacalcet + regular medical medication including vit D
Control	control	conventional treatment for secondary HPT including vit D and phosphate binder

Primary Outcome Measures

Name	Time	Method
> 30% reduction from baseline of intact parathyroid hormone (iPTH)	20 weeks

Secondary Outcome Measures

Name	Time	Method
Achievement of targets for mean Ca x P (<55 mg2/dL2), Ca (<9.5 mg/dL), P (<5.5 mg/dL)	20 weeks
Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml)	20 weeks
Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously	20 weeks
Vascular calcification score	20 weeks	Abdominal aortic calcification score (AAC, 0-24) will be measured at baseline and at 20 weeks according to Kauppila et al (Atherosclerosis 2004)
Normalization of serum alkaline phosphatase	20 weeks	Serum alkaline phosphatase measured at baseline and 20 weeks
Serum FGF-23	baseline and 20th week	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.

Trial Locations

Locations (7)

Hallym University Sacred Hospital; 🇰🇷 Pyungchon, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Gil Hospital; 🇰🇷 Incheon, Korea, Republic of

Eulji University; 🇰🇷 Seoul, Korea, Republic of

Kyungpook National University; 🇰🇷 Daegu, Korea, Republic of