A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01850641
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Apr 29, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 3, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PA21	Drug: PA21

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events [12 weeks]

Secondary Outcome Measures

1. Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) [12 weeks]

2. Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) [12 weeks]

3. Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) [12 weeks]

4. Serum Ferritin Concentrations at End of Treatment (Actual Measured Value) [12 weeks]

5. TSAT at End of Treatment (Actual Measured Value) [12 weeks]

6. Hb Concentrations at End of Treatment (Actual Measured Value) [12 weeks]

7. Constipation Condition [12 weeks]

8. Satisfaction With Bowel Movement [12 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		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: NCT01850641
• Other Study ID Numbers: PA1304
• First Posted: May 9, 2013
• Last Update Posted: Oct 9, 2018
• Last Verified: Nov 1, 2014

• 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	35
COMPLETED	30
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	PA21
Arm/Group Description	PA21
Overall Participants	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.7 (8.0)
Sex: Female, Male (Count of Participants)
Female	14 40%
Male	21 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	35 100%
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]	111.1 (87.5)

Outcome Measures

1. Primary Outcome

Title	Incidence of Adverse Events
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	35
Count of Participants [Participants]	28 80%

2. Secondary Outcome

Title	Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	35
Mean (Standard Deviation) [mg/dL]	4.89 (1.14)

3. Secondary Outcome

Title	Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	35
Mean (Standard Deviation) [mg/dL]	9.52 (0.88)

4. Secondary Outcome

Title	Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	35
Mean (Standard Deviation) [pg/mL]	177.9 (146.4)

5. Secondary Outcome

Title	Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	35
Median (Inter-Quartile Range) [ng/mL]	73.8

6. Secondary Outcome

Title	TSAT at End of Treatment (Actual Measured Value)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	35
Mean (Standard Deviation) [percentage of TSAT]	27.72 (8.27)

7. Secondary Outcome

Title	Hb Concentrations at End of Treatment (Actual Measured Value)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	35
Mean (Standard Deviation) [g/dL]	11.22 (1.19)

8. Secondary Outcome

Title	Constipation Condition
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	35
Not at all bothersome	15 42.9%
Bothers me very little	14 40%
Somewhat bothersome	2 5.7%
Bothers me quite a lot	4 11.4%
Could not tolerate	0 0%
Not at all bothersome	26 74.3%
Bothers me very little	5 14.3%
Somewhat bothersome	2 5.7%
Bothers me quite a lot	2 5.7%
Could not tolerate	0 0%

9. Secondary Outcome

Title	Satisfaction With Bowel Movement
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	PA21
Arm/Group Description	PA21
Measure Participants	35
Very much satisfied/Satisfied	21 60%
Can say neither	8 22.9%
Very much dissatisfied/Dissatisfied	6 17.1%
Very much satisfied/Satisfied	28 80%
Can say neither	5 14.3%
Very much dissatisfied/Dissatisfied	2 5.7%

Adverse Events

Arm/Group Title	PA21
Arm/Group Description	PA21
All Cause Mortality
	PA21
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Serious Adverse Events
	PA21
	Affected / at Risk (%)	# Events
Total	1/35 (2.9%)
Hepatobiliary disorders
Hepatitis acute	1/35 (2.9%)
Other (Not Including Serious) Adverse Events
	PA21
	Affected / at Risk (%)	# Events
Total	23/35 (65.7%)
Gastrointestinal disorders
Diarrhoea	14/35 (40%)
Infections and infestations
Nasopharyngitis	10/35 (28.6%)
Injury, poisoning and procedural complications
Wound	2/35 (5.7%)
Musculoskeletal and connective tissue disorders
Back pain	2/35 (5.7%)
Skin and subcutaneous tissue disorders
Dermatitis contact	2/35 (5.7%)
Haemorrhage subcutaneous	2/35 (5.7%)

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.