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NCT01852682 Clinical Trial

A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia

Hyperphosphatemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01852682
Other study ID # PA1303
Secondary ID
Status Completed
Phase Phase 3
First received May 7, 2013
Last updated November 11, 2014

Study information
Verified date November 2014
Source Kissei Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date March 2014
Accepts healthy volunteers
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Receiving stable maintenance peritoneal dialysis

- Peritoneal dialysis patients with hyperphosphatemia

Exclusion Criteria:

- Patients having history of a pronounced brain / cardiovascular disorder

- Patients having severe gastrointestinal disorders

- Patients having severe hepatic disorders

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PA21

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum phosphate concentrations 12 weeks No
Secondary Incidences of Adverse Events 12 weeks Yes
Secondary Incidences of Adverse Events 28 weeks Yes
Secondary Serum phosphate concentrations 28 weeks No
See also
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Unknown status NCT01245517 - The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient N/A
Completed NCT01252771 - Phosphate Kinetic Modeling 2 Phase 4
Completed NCT01187628 - Long-term Study in Chronic Kidney Disease (Extension From Study 14817) Phase 3
Completed NCT00506441 - A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia Phase 3
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Completed NCT01003223 - Phosphate Kinetic Modeling N/A
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Completed NCT00508885 - The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients Phase 1/Phase 2
Completed NCT04551300 - A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients Phase 2
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Completed NCT03861247 - Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients Phase 3
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Completed NCT00542815 - A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia Phase 3
Completed NCT04549597 - Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia Phase 4