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

Primary Purpose

Secondary Hyperparathyroidism

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cinacalcet
control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring peritoneal dialysis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Seoul National University Hospital
  • Kyungpook National University
  • Gil Hospital
  • Hallym University Sacred Hospital
  • Seoul National University Bundang Hospital
  • Eulji University
  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cinacalcet

Control

Arm Description

stepwise dose of cinacalcet + regular medical medication including vit D

conventional treatment for secondary HPT including vit D and phosphate binder

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml)
Achievement of targets for mean Ca x P (<55 mg2/dL2), Ca (<9.5 mg/dL), P (<5.5 mg/dL)
Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously
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)
Normalization of serum alkaline phosphatase
Serum alkaline phosphatase measured at baseline and 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.

Full Information

First Posted
April 4, 2010
Last Updated
June 6, 2012
Sponsor
Seoul National University Hospital
Collaborators
Jeil-Kirin Pharmaceutical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01101113
Brief Title
Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level
Acronym
CUPID
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Jeil-Kirin Pharmaceutical Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
peritoneal dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cinacalcet
Arm Type
Experimental
Arm Description
stepwise dose of cinacalcet + regular medical medication including vit D
Arm Title
Control
Arm Type
Active Comparator
Arm Description
conventional treatment for secondary HPT including vit D and phosphate binder
Intervention Type
Drug
Intervention Name(s)
cinacalcet
Intervention Description
cinacalcet 25mg qd or 50 mg qd
Intervention Type
Drug
Intervention Name(s)
control
Intervention Description
vit D + P binder
Primary Outcome Measure Information:
Title
> 30% reduction from baseline of intact parathyroid hormone (iPTH)
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml)
Time Frame
20 weeks
Title
Achievement of targets for mean Ca x P (<55 mg2/dL2), Ca (<9.5 mg/dL), P (<5.5 mg/dL)
Time Frame
20 weeks
Title
Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously
Time Frame
20 weeks
Title
Vascular calcification score
Description
Abdominal aortic calcification score (AAC, 0-24) will be measured at baseline and at 20 weeks according to Kauppila et al (Atherosclerosis 2004)
Time Frame
20 weeks
Title
Normalization of serum alkaline phosphatase
Description
Serum alkaline phosphatase measured at baseline and 20 weeks
Time Frame
20 weeks
Title
Serum FGF-23
Description
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.
Time Frame
baseline and 20th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Kyungpook National University
City
Daegu
Country
Korea, Republic of
Facility Name
Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Hallym University Sacred Hospital
City
Pyungchon
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Eulji University
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23705925
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.
Results Reference
derived

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

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