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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01101113
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : June 8, 2012
Jeil-Kirin Pharmaceutical Inc.
Information provided by (Responsible Party):
Kook-Hwan Oh, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Drug: cinacalcet Drug: control Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Cinacalcet Efficacy in Combination With Vitamin D for the Treatment of Secondary Hyperparathyroidism in Peritoneal Dialysis Patients
Study Start Date : September 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Vitamin D

Arm Intervention/treatment
Experimental: Cinacalcet
stepwise dose of cinacalcet + regular medical medication including vit D
Drug: cinacalcet
cinacalcet 25mg qd or 50 mg qd

Active Comparator: Control
conventional treatment for secondary HPT including vit D and phosphate binder
Drug: control
vit D + P binder

Primary Outcome Measures :
  1. > 30% reduction from baseline of intact parathyroid hormone (iPTH) [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml) [ Time Frame: 20 weeks ]
  2. 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 ]
  3. Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously [ Time Frame: 20 weeks ]
  4. 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)

  5. Normalization of serum alkaline phosphatase [ Time Frame: 20 weeks ]
    Serum alkaline phosphatase measured at baseline and 20 weeks

  6. 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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01101113

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Korea, Republic of, 110-744
Kyungpook National University
Daegu, Korea, Republic of
Gil Hospital
Incheon, Korea, Republic of
Hallym University Sacred Hospital
Pyungchon, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Eulji University
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Jeil-Kirin Pharmaceutical Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kook-Hwan Oh, Associate Professor, Seoul National University Hospital Identifier: NCT01101113    
Other Study ID Numbers: CINA-Kor-01
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012
Keywords provided by Kook-Hwan Oh, Seoul National University Hospital:
peritoneal dialysis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism, Secondary
Neoplastic Processes
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists