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

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01852682
• Collaborator: (none)
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Dialysis; Hyperphosphatemia	Drug: PA21	Phase 3

Study Design

• Study Type: Interventional
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Primary Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PA21	Drug: PA21

Outcome Measures

Primary Outcome Measures

1. Serum phosphate concentrations [12 weeks]

Secondary Outcome Measures

1. Incidences of Adverse Events [12 weeks]

2. Incidences of Adverse Events [28 weeks]

3. Serum phosphate concentrations [28 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Tokyo and Other Japanese City		Japan

Sponsors and Collaborators

• Kissei Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kissei Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01852682
• Other Study ID Numbers: PA1303
• First Posted: May 14, 2013
• Last Update Posted: Nov 13, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Kissei Pharmaceutical Co., Ltd.: Peritoneal Dialysis; Hyperphosphatemia
• Additional relevant MeSH terms: Hyperphosphatemia

Study Results

No Results Posted as of Nov 13, 2014