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CompletedNCT01833494Updated Oct 9, 2018Results posted

A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

A Phase 3 interventional study of PA21 in Hemodialysis Patients With Hyperphosphatemia, sponsored by Kissei Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Kissei Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
161
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.

02

Conditions studied

  • Hemodialysis Patients With Hyperphosphatemia

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Keywords

  • Hemodialysis
  • Hyperphosphatemia
03

In context

Hyperphosphatemia

148 studies on the registry are indexed under Hyperphosphatemia; 10 are open to participants now.

This study's enrollment of 161 is above the median of 110 across 124 interventional studies indexed under Hyperphosphatemia.

Browse Hyperphosphatemia studies →

Lead sponsor

Kissei Pharmaceutical Co., Ltd. is the lead sponsor of 61 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Receiving stable maintenance hemodialysis 3 times a week.
  • Dialysis patients with hyperphosphatemia

Exclusion criteria

Exclusion Criteria:

  • Patients having history of a pronounced brain / cardiovascular disorder.
  • Patients having severe gastrointestinal disorders.
  • Patients having severe hepatic disorders.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
161 participants (actual)

Study arms

  • Experimental
    PA21

    Drug: PA21

Interventions

  • DrugPA21
06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: 52 weeks

Secondary outcomes

  1. Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)

    Time frame: 52 weeks

  2. Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)

    Time frame: 52 weeks

  3. Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)

    Time frame: 52 weeks

07

Results

Posted Oct 9, 2018

Participant flow

Participant flow — Overall Study
MilestonePA21
Started161
Completed116
Not completed45
Withdrew: Adverse event24
Withdrew: Physician decision6
Withdrew: Withdrawal by subject6
Withdrew: Decrease in serum phosphorus4
Withdrew: Decrease in serum calcium4
Withdrew: Increase in serum ferritin1

Outcome measures

PrimaryIncidence of Adverse Events
Time frame:
52 weeks
Reported as:
Count of participants · Participants
Incidence of Adverse Events
ParticipantsPA21
Incidence of Adverse Events152
SecondarySerum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Time frame:
52 weeks
Reported as:
Mean · mg/dL
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
mg/dLPA21
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)5.00 ± 1.17
SecondaryCorrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Time frame:
52 weeks
Reported as:
Mean · mg/dL
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
mg/dLPA21
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)9.05 ± 0.70
SecondarySerum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Time frame:
52 weeks
Reported as:
Mean · pg/mL
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
pg/mLPA21
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)251.6 ± 151.4

Adverse events

Collected over 52 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PA213/161 (1.9%)29/161 (18%)133/161 (82.6%)
Most frequent serious events
Showing 10 of 27
Most frequent serious events
EventPA21
Shunt occlusionInjury, poisoning and procedural complications4/161
Shunt malfunctionInjury, poisoning and procedural complications4/161
Subarachnoid haemorrhageNervous system disorders2/161
Angina pectorisCardiac disorders2/161
HaematomaVascular disorders2/161
Shunt stenosisInjury, poisoning and procedural complications2/161
PyelonephritisInfections and infestations1/161
Renal cyst infectionInfections and infestations1/161
Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/161
Altered state of consciousnessNervous system disorders1/161
Most frequent other events
Showing 10 of 13
Most frequent other events
EventPA21
NasopharyngitisInfections and infestations96/161
DiarrhoeaGastrointestinal disorders60/161
ContusionInjury, poisoning and procedural complications27/161
Procedural hypotensionInjury, poisoning and procedural complications15/161
Pain in extremityMusculoskeletal and connective tissue disorders14/161
ExcoriationInjury, poisoning and procedural complications14/161
ArthralgiaMusculoskeletal and connective tissue disorders12/161
Back painMusculoskeletal and connective tissue disorders12/161
GastroenteritisInfections and infestations10/161
WoundInjury, poisoning and procedural complications10/161

Baseline characteristics

Full Analysis Set

Age, Continuous
Age, Continuous(years)PA21
Mean58.5 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)PA21
Female47
Male113
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PA21
American Indian or Alaska Native0
Asian160
Native Hawaiian or Other Pacific Islander0
Black or African American0
White0
More than one race0
Unknown or Not Reported0
Dialysis vintage
Dialysis vintage(months)PA21
Mean85.3 ± 63.2
08

Study locations

1 site
  • JAPAN
    Multiple Locations, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01833494
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 17, 2013
Start date
Mar 18, 2013
Primary completion
Aug 2014
Completion
Aug 4, 2014
Results posted
Oct 9, 2018
Last update
Oct 9, 2018
View the source record on ClinicalTrials.gov ↗

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