Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01101113
Other study ID # CINA-Kor-01
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02549417 - Phase 3 Study of KHK7580 Phase 3
Completed NCT02549404 - Phase 3 Study of KHK7580 Phase 3
Not yet recruiting NCT02536287 - Comparison of Total Parathyroidectomy With and Without Autotransplantation Phase 3
Completed NCT02549391 - Phase 3 Study of KHK7580 Phase 2/Phase 3
Active, not recruiting NCT03023748 - Intravenous Paricalcitol in Chronic Hemodialysis Patients Phase 4
Withdrawn NCT01426724 - Effects of Vitamin D on Renal Blood Flow, Proteinuria and Inflammation in Patients With Chronic Kidney Disease N/A
Completed NCT01220050 - Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism Phase 2
Completed NCT00537979 - Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis Phase 4
Completed NCT00431496 - A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD) Phase 4
Completed NCT00379899 - ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis Phase 4
Completed NCT00117052 - SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism Phase 3
Completed NCT00073710 - Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium Phase 4
Completed NCT03626948 - SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis Phase 3
Completed NCT01382212 - A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis Phase 3
Completed NCT01219855 - Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT) Phase 2/Phase 3
Completed NCT01224782 - Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT) N/A
Completed NCT00999037 - FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease N/A
Completed NCT00990704 - Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism Phase 2
Completed NCT00742716 - Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease Phase 2
Recruiting NCT06126016 - A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.