An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis

• Sponsor: Relypsa, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02033317
• Collaborator: (none)
• Enrollment: 6
• Locations: 2
• Arm: 1
• Duration (Months): 4
• Patients Per Site: 3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.

Condition or Disease	Intervention/Treatment	Phase
Hyperkalemia	Drug: patiromer	Phase 2

Detailed Description

The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study.

This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. Eligible participants on hemodialysis were to remain in the Clinical Research Unit for 2 weeks (Day -7 to Day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Hemodialysis Patients
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patiromer	Drug: patiromer; 15 grams/day (5 grams 3 times daily) administered orally; Other Names: RLY5016 for Oral Suspension Veltassa

Outcome Measures

Primary Outcome Measures

1. Change in Serum Potassium (Day 1 to Day 8) [Day 1 and Day 8]

2. Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7) [Day -7 Through Day -1 and Day 1 Through Day 7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants on hemodialysis between the ages of 18 and 70 years, with serum potassium levels of at least 5.5 mmol/L

• Adequately dialyzed (Kt/V ≥ 1.2)

Exclusion Criteria:

• History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery.

• Severe constipation or irregular bowel habits.

• Unable to consume or tolerate the study-specific diet.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigator Site	Orlando	Florida	United States	32809
2	Investigator Site	Minneapolis	Minnesota	United States	55404

Sponsors and Collaborators

• Relypsa, Inc.

Investigators

• Study Director: VP Clinical Development, Relypsa, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Relypsa, Inc.
• ClinicalTrials.gov Identifier: NCT02033317
• Other Study ID Numbers: RLY5016-201
• First Posted: Jan 10, 2014
• Last Update Posted: May 12, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Hyperkalemia

Study Results

Participant Flow

Pre-assignment Detail	The study population consisted of participants on hemodialysis between the ages of 18 and 70 years, with pre-dialysis serum potassium levels of at least 5.5 mmol/L prior to the study.

Arm/Group Title	Patiromer
Arm/Group Description	15 grams/day (5 grams 3 times daily) patiromer administered orally
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Patiromer
Arm/Group Description	15 grams/day (5 grams 3 times daily) patiromer administered orally
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	49.7
Sex: Female, Male (Count of Participants)
Female	1 16.7%
Male	5 83.3%

Outcome Measures

1. Primary Outcome

Title	Change in Serum Potassium (Day 1 to Day 8)
Time Frame	Day 1 and Day 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	15 grams/day (5 grams 3 times daily) patiromer administered orally
Measure Participants	6
Mean (Standard Deviation) [mmol/L]	-0.23 (0.327)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patiromer
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	= 0.14
	Comments
	Method	paired t-test
	Comments

2. Primary Outcome

Title	Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)
Time Frame	Day -7 Through Day -1 and Day 1 Through Day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	15 grams/day (5 grams 3 times daily) patiromer administered orally
Measure Participants	6
Mean (Standard Deviation) [mg/Day]	359 (277)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patiromer
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	= 0.02
	Comments
	Method	paired t-test
	Comments

Adverse Events

Time Frame	Up to 10 days after Day 8 or last patiromer dose, whichever was earlier.
Adverse Event Reporting Description	Participants who received at least one dose of trial medication.
Arm/Group Title	Patiromer
Arm/Group Description	15 grams/day (5 grams 3 times daily) patiromer administered orally.
All Cause Mortality
	Patiromer
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Patiromer
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	Patiromer
	Affected / at Risk (%)	# Events
Total	2/6 (33.3%)
Gastrointestinal disorders
Abdominal Rigidity	1/6 (16.7%)
Nausea	1/6 (16.7%)
Infections and infestations
Furuncle	1/6 (16.7%)

Limitations/Caveats

The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study.

More Information

Certain Agreements

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

Our agreements generally provide that PI cannot publish single site data before publication of the multi-site publication, unless 1 year has elapsed since completion of the study at all sites. Thereafter, PI may publish provided that PI shall: provide a copy of the publication to sponsor at least 60 days in advance of submission for publication; delete sponsor's confidential information as requested; and delay publication up to an additional 90 days to permit protection of intellectual property.