- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01101113
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
Conditions
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
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-
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Daegu, Korea, Republic of
- Kyungpook National University
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Incheon, Korea, Republic of
- Gil Hospital
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Pyungchon, Korea, Republic of
- Hallym University Sacred Hospital
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Seongnam, Korea, Republic of
- Seoul National University Bundang Hospital
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Seoul, Korea, Republic of
- Samsung Medical Center
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Seoul, Korea, Republic of
- Eulji University
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Korea
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Seoul, Korea, Korea, Republic of, 110-744
- Seoul National University Hospital
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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
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Active Comparator: Control
conventional treatment for secondary HPT including vit D and phosphate binder
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vit D + P binder
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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
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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
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20 weeks
|
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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
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20 weeks
|
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Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously
Time Frame: 20 weeks
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20 weeks
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Vascular calcification score
Time Frame: 20 weeks
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Abdominal aortic calcification score (AAC, 0-24) will be measured at baseline and at 20 weeks according to Kauppila et al (Atherosclerosis 2004)
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20 weeks
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Normalization of serum alkaline phosphatase
Time Frame: 20 weeks
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Serum alkaline phosphatase measured at baseline and 20 weeks
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20 weeks
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Serum FGF-23
Time Frame: baseline and 20th week
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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.
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baseline and 20th week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Endocrine System Diseases
- Parathyroid Diseases
- Neoplastic Processes
- Hyperparathyroidism
- Neoplasm Metastasis
- Hyperparathyroidism, Secondary
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Calcium-Regulating Hormones and Agents
- Calcimimetic Agents
- Cinacalcet
Other Study ID Numbers
- CINA-Kor-01
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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