A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

Sponsor
Kissei Pharmaceutical Co., Ltd.
Study ID
NCT01850602
Phase
PHASE3
Status
Completed

Conditions

  • Hemodialysis
  • Hyperphosphatemia

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PA21 — DRUG
  • Sevelamer hydrochloride — DRUG

Study Details

The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia

Key Dates

Start date
Apr 23, 2013
Status verified
Nov 2014
Primary completion
Dec 31, 2013
Completion
Dec 10, 2013

Study Design

Enrollment
213 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PA21
  • Active Comparator: Sevelamer hydrochloride

Primary Outcome Measure

Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment [ Time Frame: 12 weeks ]

Related Studies