A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01850602
• Collaborator: (none)
• Enrollment: 213
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.6
• Patients Per Site Per Month: 28.1

Study Details

Study Description

Brief Summary

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 213 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Apr 23, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 10, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PA21	Drug: PA21
Active Comparator: Sevelamer hydrochloride	Drug: Sevelamer hydrochloride

Outcome Measures

Primary Outcome Measures

1. Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment [12 weeks]

   Covariate: Serum phosphorus concentrations at baseline.

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]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients age 20 or older, regardless of gender.

• Receiving stable maintenance hemodialysis 3 times a week.

• Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.

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: NCT01850602
• Other Study ID Numbers: PA1301
• 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; Sevelamer

Study Results

Participant Flow

Arm/Group Title	PA21	Sevelamer Hydrochloride
Arm/Group Description	PA21	Sevelamer hydrochloride
Period Title: Overall Study
STARTED	108	105
COMPLETED	94	87
NOT COMPLETED	14	18

Baseline Characteristics

Arm/Group Title	PA21	Sevelamer Hydrochloride	Total
Arm/Group Description	PA21	Sevelamer hydrochloride	Total of all reporting groups
Overall Participants	100	92	192
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.0 (11.7)	60.8 (12.0)	60.9 (11.8)
Sex: Female, Male (Count of Participants)
Female	28 28%	39 42.4%	67 34.9%
Male	72 72%	53 57.6%	125 65.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	100 100%	92 100%	192 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Dialysis vintage (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	104.9 (79.7)	102.4 (90.6)	103.7 (84.8)

Outcome Measures

1. Primary Outcome

Title	Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
Description	Covariate: Serum phosphorus concentrations at baseline.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Per Protocol Set

Arm/Group Title	PA21	Sevelamer Hydrochloride
Arm/Group Description	PA21	Sevelamer hydrochloride
Measure Participants	100	92
Mean (95% Confidence Interval) [mg/dL]	5.00	5.34

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PA21, Sevelamer Hydrochloride
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-Inferiority margin: 1.0 mg/dL Non-Inferiority was considerd to be confirmed if the upper limit of two-sided confidence interval became 1.0 mg/dL or less.
Statistical Test of Hypothesis	p-Value	0.020
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 95%; -0.63 to -0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol Set

Arm/Group Title	PA21	Sevelamer Hydrochloride
Arm/Group Description	PA21	Sevelamer hydrochloride
Measure Participants	100	92
Mean (Standard Deviation) [mg/dL]	5.01 (1.01)	5.33 (1.03)

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

Per Protocol Set

Arm/Group Title	PA21	Sevelamer Hydrochloride
Arm/Group Description	PA21	Sevelamer hydrochloride
Measure Participants	100	92
Mean (Standard Deviation) [mg/dL]	9.14 (0.68)	8.91 (0.71)

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

Per Protocol Set

Arm/Group Title	PA21	Sevelamer Hydrochloride
Arm/Group Description	PA21	Sevelamer hydrochloride
Measure Participants	100	92
Mean (Standard Deviation) [pg/mL]	203.6 (117.1)	253.1 (168.6)

Adverse Events

Time Frame	12 weeks
Arm/Group Title	PA21		Sevelamer Hydrochloride
Arm/Group Description	PA21		Sevelamer hydrochloride
All Cause Mortality
	PA21		Sevelamer Hydrochloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/108 (0%)		0/105 (0%)
Serious Adverse Events
	PA21		Sevelamer Hydrochloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/108 (5.6%)		5/105 (4.8%)
Cardiac disorders
Cardiac failure congestive	1/108 (0.9%)		0/105 (0%)
Supraventricular tachycardia	1/108 (0.9%)		0/105 (0%)
Infections and infestations
Diverticulitis	0/108 (0%)		1/105 (1%)
Pneumonia	1/108 (0.9%)		0/105 (0%)
Injury, poisoning and procedural complications
Shunt stenosis	0/108 (0%)		1/105 (1%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/108 (0%)		1/105 (1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/108 (0.9%)		0/105 (0%)
Gastric cancer	0/108 (0%)		1/105 (1%)
Nervous system disorders
Cerebral infarction	0/108 (0%)		1/105 (1%)
Renal and urinary disorders
Renal cyst ruptured	1/108 (0.9%)		0/105 (0%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	1/108 (0.9%)		0/105 (0%)
Pulmonary oedema	1/108 (0.9%)		0/105 (0%)
Other (Not Including Serious) Adverse Events
	PA21		Sevelamer Hydrochloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	47/108 (43.5%)		42/105 (40%)
Gastrointestinal disorders
Constipation	2/108 (1.9%)		19/105 (18.1%)
Diarrhoea	27/108 (25%)		3/105 (2.9%)
Infections and infestations
Nasopharyngitis	24/108 (22.2%)		24/105 (22.9%)

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.