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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01101113

Acronym

CUPID

Enrollment

Registered

2010-04-09

Start date

2010-09-30

Completion date

2012-06-30

Last updated

2012-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Hyperparathyroidism

Keywords

peritoneal dialysis

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.

Interventions

DRUGcinacalcet

cinacalcet 25mg qd or 50 mg qd

DRUGcontrol

vit D + P binder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—
Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml)	20 weeks	—
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.
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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026