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

June 6, 2012 updated by: Kook-Hwan Oh, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Daegu, Korea, Republic of
        • Kyungpook National University
      • Incheon, Korea, Republic of
        • Gil Hospital
      • Pyungchon, Korea, Republic of
        • Hallym University Sacred Hospital
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Eulji University
    • Korea
      • Seoul, Korea, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml)
Time Frame: 20 weeks
20 weeks
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
20 weeks
Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously
Time Frame: 20 weeks
20 weeks
Vascular calcification score
Time Frame: 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)
20 weeks
Normalization of serum alkaline phosphatase
Time Frame: 20 weeks
Serum alkaline phosphatase measured at baseline and 20 weeks
20 weeks
Serum FGF-23
Time Frame: 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.
baseline and 20th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 4, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 9, 2010

Study Record Updates

Last Update Posted (Estimate)

June 8, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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