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

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01833494
• Collaborator: (none)
• Enrollment: 161
• Location: 1
• Arm: 1
• Actual Duration (Months): 16.6
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis Patients With Hyperphosphatemia	Drug: PA21	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 161 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
• Actual Study Start Date: Mar 18, 2013
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 4, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PA21	Drug: PA21

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events [52 weeks]

Secondary Outcome Measures

1. Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) [52 weeks]

2. Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) [52 weeks]

3. Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) [52 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Receiving stable maintenance hemodialysis 3 times a week.

• 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	JAPAN	Multiple Locations		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: NCT01833494
• Other Study ID Numbers: PA1302
• First Posted: Apr 17, 2013
• Last Update Posted: Oct 9, 2018
• Last Verified: Apr 1, 2015

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

Study Results

Participant Flow

Arm/Group Title	PA21
Arm/Group Description	PA21
Period Title: Overall Study
STARTED	161
COMPLETED	116
NOT COMPLETED	45

Baseline Characteristics

Arm/Group Title	PA21
Arm/Group Description	PA21
Overall Participants	160
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.5 (11.1)
Sex: Female, Male (Count of Participants)
Female	47 29.4%
Male	113 70.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	160 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Dialysis vintage (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	85.3 (63.2)

Outcome Measures

1. Primary Outcome

Title	Incidence of Adverse Events
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	161
Count of Participants [Participants]	152 95%

2. Secondary Outcome

Title	Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	160
Mean (Standard Deviation) [mg/dL]	5.00 (1.17)

3. Secondary Outcome

Title	Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	160
Mean (Standard Deviation) [mg/dL]	9.05 (0.70)

4. Secondary Outcome

Title	Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	158
Mean (Standard Deviation) [pg/mL]	251.6 (151.4)

Adverse Events

Time Frame	52 weeks
Arm/Group Title	PA21
Arm/Group Description	PA21
All Cause Mortality
	PA21
	Affected / at Risk (%)	# Events
Total	3/161 (1.9%)
Serious Adverse Events
	PA21
	Affected / at Risk (%)	# Events
Total	29/161 (18%)
Cardiac disorders
Angina pectoris	2/161 (1.2%)
Arteriosclerosis coronary artery	1/161 (0.6%)
Cardiac failure congestive	1/161 (0.6%)
Ventricular fibrillation	1/161 (0.6%)
Eye disorders
Cataract	1/161 (0.6%)
Retinal haemorrhage	1/161 (0.6%)
Vitreous haemorrhage	1/161 (0.6%)
Macular fibrosis	1/161 (0.6%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/161 (0.6%)
Ileus	1/161 (0.6%)
General disorders
Pyrexia	1/161 (0.6%)
Infections and infestations
Pyelonephritis	1/161 (0.6%)
Renal cyst infection	1/161 (0.6%)
Injury, poisoning and procedural complications
Shunt occlusion	4/161 (2.5%)
Contusion	1/161 (0.6%)
Shunt stenosis	2/161 (1.2%)
Shunt malfunction	4/161 (2.5%)
Shunt aneurysm	1/161 (0.6%)
Musculoskeletal and connective tissue disorders
Jaw cyst	1/161 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	1/161 (0.6%)
Nervous system disorders
Altered state of consciousness	1/161 (0.6%)
Subarachnoid haemorrhage	2/161 (1.2%)
Transient ischaemic attack	1/161 (0.6%)
VIIth nerve paralysis	1/161 (0.6%)
Renal and urinary disorders
Renal cyst haemorrhage	1/161 (0.6%)
Vascular disorders
Haematoma	2/161 (1.2%)
Venous stenosis	1/161 (0.6%)
Other (Not Including Serious) Adverse Events
	PA21
	Affected / at Risk (%)	# Events
Total	133/161 (82.6%)
Gastrointestinal disorders
Constipation	9/161 (5.6%)
Dental caries	9/161 (5.6%)
Diarrhoea	60/161 (37.3%)
Infections and infestations
Gastroenteritis	10/161 (6.2%)
Nasopharyngitis	96/161 (59.6%)
Injury, poisoning and procedural complications
Excoriation	14/161 (8.7%)
Contusion	27/161 (16.8%)
Wound	10/161 (6.2%)
Procedural hypotension	15/161 (9.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	12/161 (7.5%)
Back pain	12/161 (7.5%)
Pain in extremity	14/161 (8.7%)
Skin and subcutaneous tissue disorders
Eczema	9/161 (5.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.