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

Secondary Hyperparathyroidism Clinical Trial

— CUPID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101113
• Other study ID #: CINA-Kor-01
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2010
• Last updated: June 6, 2012
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board, Seoul National University Hospital
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Secondary Hyperparathyroidism

Intervention

Drug:
• cinacalcet
cinacalcet 25mg qd or 50 mg qd
• control
vit D + P binder

Locations

Country	Name	City	State
Korea, Republic of	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	Seoul National University Hospital	Seoul	Korea

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Jeil-Kirin Pharmaceutical Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	> 30% reduction from baseline of intact parathyroid hormone (iPTH)		20 weeks	No
Secondary	Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml)		20 weeks	No
Secondary	Achievement of targets for mean Ca x P (<55 mg2/dL2), Ca (<9.5 mg/dL), P (<5.5 mg/dL)		20 weeks	No
Secondary	Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously		20 weeks	No
Secondary	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)	20 weeks	No
Secondary	Normalization of serum alkaline phosphatase	Serum alkaline phosphatase measured at baseline and 20 weeks	20 weeks	No
Secondary	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.	baseline and 20th week	No