Clinical trial NCT01101113: Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level
Official title: Phase 4 Study of Cinacalcet Efficacy in Combination With Vitamin D for the Treatment of Secondary Hyperparathyroidism in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
Keywords: peritoneal dialysis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Jeil-Kirin Pharmaceutical Inc.
First posted: 2010-04-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: > 30% reduction from baseline of intact parathyroid hormone (iPTH)
timeFrame: 20 weeks
Secondary outcomes:
measure: Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml)
timeFrame: 20 weeks
measure: Achievement of targets for mean Ca x P (<55 mg2/dL2), Ca (<9.5 mg/dL), P (<5.5 mg/dL)
timeFrame: 20 weeks
measure: Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously
timeFrame: 20 weeks
measure: Vascular calcification score
timeFrame: 20 weeks
measure: Normalization of serum alkaline phosphatase
timeFrame: 20 weeks
measure: Serum FGF-23
timeFrame: baseline and 20th week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Korea
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University
city: Incheon
country: Korea, Republic of
facility: Gil Hospital
city: Pyungchon
country: Korea, Republic of
facility: Hallym University Sacred Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Kim HJ, Kim H, Shin N, Na KY, Kim YL, Kim D, Chang JH, Song YR, Hwang YH, Kim YS, Ahn C, Lee J, Oh KH; Representing the Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect Of iPTH Level (CUPID) Study Group. Cinacalcet lowering of serum fibroblast growth factor-23 concentration may be independent from serum Ca, P, PTH and dose of active vitamin D in peritoneal dialysis patients: a randomized controlled study. BMC Nephrol. 2013 May 25;14:112. doi: 10.1186/1471-2369-14-112.