Trial Outcomes & Findings for A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia (NCT NCT01833494)

NCT ID: NCT01833494

Last Updated: 2018-10-09

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

161 participants

Primary outcome timeframe

52 weeks

Results posted on

2018-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	PA21 PA21
Overall Study STARTED	161
Overall Study COMPLETED	116
Overall Study NOT COMPLETED	45

Reasons for withdrawal

Reasons for withdrawal
Measure	PA21 PA21
Overall Study Adverse Event	24
Overall Study Physician Decision	6
Overall Study Withdrawal by Subject	6
Overall Study Decrease in serum phosphorus	4
Overall Study Decrease in serum calcium	4
Overall Study Increase in serum ferritin	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PA21 n=160 Participants PA21
Age, Continuous	58.5 years STANDARD_DEVIATION 11.1 • n=99 Participants
Sex: Female, Male Female	47 Participants n=99 Participants
Sex: Female, Male Male	113 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	160 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Dialysis vintage	85.3 months STANDARD_DEVIATION 63.2 • n=99 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Safety Set

Outcome measures

Outcome measures
Measure	PA21 n=161 Participants PA21
Incidence of Adverse Events	152 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	PA21 n=160 Participants PA21
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)	5.00 mg/dL Standard Deviation 1.17

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	PA21 n=160 Participants PA21
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)	9.05 mg/dL Standard Deviation 0.70

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	PA21 n=158 Participants PA21
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)	251.6 pg/mL Standard Deviation 151.4

Adverse Events

PA21

Serious events: 29 serious events

Other events: 133 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	PA21 n=161 participants at risk PA21
Infections and infestations Pyelonephritis	0.62% 1/161 • 52 weeks
Infections and infestations Renal cyst infection	0.62% 1/161 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.62% 1/161 • 52 weeks
Nervous system disorders Altered state of consciousness	0.62% 1/161 • 52 weeks
Nervous system disorders Subarachnoid haemorrhage	1.2% 2/161 • 52 weeks
Nervous system disorders Transient ischaemic attack	0.62% 1/161 • 52 weeks
Nervous system disorders VIIth nerve paralysis	0.62% 1/161 • 52 weeks
Eye disorders Cataract	0.62% 1/161 • 52 weeks
Eye disorders Retinal haemorrhage	0.62% 1/161 • 52 weeks
Eye disorders Vitreous haemorrhage	0.62% 1/161 • 52 weeks
Eye disorders Macular fibrosis	0.62% 1/161 • 52 weeks
Cardiac disorders Angina pectoris	1.2% 2/161 • 52 weeks
Cardiac disorders Arteriosclerosis coronary artery	0.62% 1/161 • 52 weeks
Cardiac disorders Cardiac failure congestive	0.62% 1/161 • 52 weeks
Cardiac disorders Ventricular fibrillation	0.62% 1/161 • 52 weeks
Vascular disorders Haematoma	1.2% 2/161 • 52 weeks
Vascular disorders Venous stenosis	0.62% 1/161 • 52 weeks
Gastrointestinal disorders Gastrointestinal haemorrhage	0.62% 1/161 • 52 weeks
Gastrointestinal disorders Ileus	0.62% 1/161 • 52 weeks
Musculoskeletal and connective tissue disorders Jaw cyst	0.62% 1/161 • 52 weeks
Renal and urinary disorders Renal cyst haemorrhage	0.62% 1/161 • 52 weeks
General disorders Pyrexia	0.62% 1/161 • 52 weeks
Injury, poisoning and procedural complications Shunt occlusion	2.5% 4/161 • 52 weeks
Injury, poisoning and procedural complications Contusion	0.62% 1/161 • 52 weeks
Injury, poisoning and procedural complications Shunt stenosis	1.2% 2/161 • 52 weeks
Injury, poisoning and procedural complications Shunt malfunction	2.5% 4/161 • 52 weeks
Injury, poisoning and procedural complications Shunt aneurysm	0.62% 1/161 • 52 weeks

Other adverse events

Other adverse events
Measure	PA21 n=161 participants at risk PA21
Infections and infestations Gastroenteritis	6.2% 10/161 • 52 weeks
Infections and infestations Nasopharyngitis	59.6% 96/161 • 52 weeks
Gastrointestinal disorders Constipation	5.6% 9/161 • 52 weeks
Gastrointestinal disorders Dental caries	5.6% 9/161 • 52 weeks
Gastrointestinal disorders Diarrhoea	37.3% 60/161 • 52 weeks
Skin and subcutaneous tissue disorders Eczema	5.6% 9/161 • 52 weeks
Musculoskeletal and connective tissue disorders Arthralgia	7.5% 12/161 • 52 weeks
Musculoskeletal and connective tissue disorders Back pain	7.5% 12/161 • 52 weeks
Musculoskeletal and connective tissue disorders Pain in extremity	8.7% 14/161 • 52 weeks
Injury, poisoning and procedural complications Excoriation	8.7% 14/161 • 52 weeks
Injury, poisoning and procedural complications Contusion	16.8% 27/161 • 52 weeks
Injury, poisoning and procedural complications Wound	6.2% 10/161 • 52 weeks
Injury, poisoning and procedural complications Procedural hypotension	9.3% 15/161 • 52 weeks

Additional Information

Clinical Development Division

Kissei Pharmaceutical Co., Ltd

Phone: Email only

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place