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

This study has been completed.
Sponsor:
Collaborator:
Jeil-Kirin Pharmaceutical Inc.
Information provided by (Responsible Party):
Kook-Hwan Oh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01101113
First received: April 4, 2010
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Secondary Hyperparathyroidism
 Drug: cinacalcet
Drug: control
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Vitamin D
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • > 30% reduction from baseline of intact parathyroid hormone (iPTH) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Vascular calcification score [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Serum alkaline phosphatase measured at baseline and 20 weeks

  • Serum FGF-23 [ Time Frame: baseline and 20th week ] [ Designated as safety issue: No ]
    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.


Enrollment: 66
Study Start Date: September 2010
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101113

Locations
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
Samsung Medical Center
Seoul, Korea, Republic of
Eulji University
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Jeil-Kirin Pharmaceutical Inc.
  More Information

No publications provided

Responsible Party: Kook-Hwan Oh, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01101113     History of Changes
Other Study ID Numbers: CINA-Kor-01
Study First Received: April 4, 2010
Last Updated: June 6, 2012
Health Authority: Korea: Institutional Review Board, Seoul National University Hospital

Keywords provided by Seoul National University Hospital:
peritoneal dialysis

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013