NCT01101113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

1.5 years

First QC Date

April 4, 2010

Last Update Submit

June 6, 2012

Conditions

Secondary Hyperparathyroidism

Keywords

peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

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

    20 weeks

Secondary Outcomes (6)

  • 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

    20 weeks

  • Normalization of serum alkaline phosphatase

    20 weeks

  • +1 more secondary outcomes

Study Arms (2)

Cinacalcet

EXPERIMENTAL

stepwise dose of cinacalcet + regular medical medication including vit D

Drug: cinacalcet

Control

ACTIVE COMPARATOR

conventional treatment for secondary HPT including vit D and phosphate binder

Drug: control

Interventions

cinacalcetDRUG

cinacalcet 25mg qd or 50 mg qd

Cinacalcet
controlDRUG

vit D + P binder

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Seoul National University Hospital

Seoul, Korea, 110-744, South Korea

Location

Kyungpook National University

Daegu, South Korea

Location

Gil Hospital

Incheon, South Korea

Location

Hallym University Sacred Hospital

Pyungchon, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Eulji University

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 23705925DERIVED

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 4, 2010

First Posted

April 9, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

June 8, 2012

Record last verified: 2012-06

Locations

KR(7)