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

Study Overview
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Brief Summary
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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.

Official Title
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Phase 4 Study of Cinacalcet Efficacy in Combination With Vitamin D for the Treatment of Secondary Hyperparathyroidism in Peritoneal Dialysis Patients

Conditions
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Secondary Hyperparathyroidism

Intervention / Treatment
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* Drug: cinacalcet
* Drug: control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cinacalcet<br>stepwise dose of cinacalcet + regular medical medication including vit D | Drug: cinacalcet<br>* cinacalcet 25mg qd or 50 mg qd<br>|
| Active Comparator: Control<br>conventional treatment for secondary HPT including vit D and phosphate binder | Drug: control<br>* vit D + P binder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| > 30% reduction from baseline of intact parathyroid hormone (iPTH) |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of treatment goal of intact parathyroid hormone (iPTH) (150 300 pg/ml) |  | 20 weeks | 
| Achievement of targets for mean Ca x P (<55 mg2/dL2), Ca (<9.5 mg/dL), P (<5.5 mg/dL) |  | 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 | Abdominal aortic calcification score (AAC, 0-24) will be measured at baseline and at 20 weeks according to Kauppila et al (Atherosclerosis 2004) | 20 weeks | 
| Normalization of serum alkaline phosphatase | Serum alkaline phosphatase measured at baseline and 20 weeks | 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. | baseline and 20th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peritoneal dialysis