Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia

NCT01866709 | Terminated Phase 4 Results DMC

• 1 other identifier: SPS-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

It is hypothesized that SPS is more effective than placebo control (alternative hypothesis) in lowering i-STAT potassium levels in subjects with i-STAT potassium levels between 5.0 - 6.5 mmol/l versus no difference between SPS and placebo control (null hypothesis).

Conditions

Hyperkalemia

Outcome Measures

Primary Outcomes (1)

• Change in Serum Potassium Levels From Baseline After Administration of Sodium Polystyrene Sulfonate (SPS) Three Times a Day Without Co-administration of Sorbitol; Determine Incidence of Adverse Events.

  To perform a controlled evaluation of the safety and efficacy of 15g of SPS administered 3 times daily for 48 hours (6 doses) in patients with hyperkalemia (serum potassium levels between 5.0 - 6.5 mmol/l) at baseline.

  First 48 hours

Secondary Outcomes (1)

• Change in Serum Sodium, Magnesium, Calcium Levels From Baseline After Administration of SPS.

  First 48 hours

Study Arms (2)

Sodium Polystyrene Sulfonate

ACTIVE COMPARATOR

Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.

Drug: Sodium polystyrene sulfonate

Silicified microcrystalline cellulose

PLACEBO COMPARATOR

Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.

Drug: Silicified microcrystalline cellulose

Interventions

Sodium polystyrene sulfonate DRUG

Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.

Also known as: SPS

Sodium Polystyrene Sulfonate

Silicified microcrystalline cellulose DRUG

Oral suspension in water of placebo administered three times (tid) daily for 48 hours.

Also known as: Placebo

Silicified microcrystalline cellulose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent.
• Over 18 years of age.
• Mean i-STAT potassium values between 5.0 - 6.5 mmol/l inclusive, at screening (Study Day 0).
• Previous participation in Clinical ZS-002 or ZS-003 protocol(s). However, subjects cannot be enrolled in this study until at least 30 days have elapsed from their last dose in study ZS-003.
• Ability to have repeated blood draws or effective venous catheterization.
• Women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method) and have a negative pregnancy test at screening.
• Women who are surgically sterile or those who are post-menopausal for at least 2 years are not considered to be of child-bearing potential.

You may not qualify if:

• Pseudohyperkalemia signs and symptoms, such as excessive fist clenching hemolyzed blood specimen, severe leukocytosis or thrombocytosis.
• Subjects treated with lactulose, Xifaxan or other non-absorbed antibiotics for hyperammonemia within the last 7 days.
• Subjects treated with resins (such as Sevelamer acetate), calcium acetate, calcium carbonate, or lanthanum carbonate, within the last 7 days.
• Subjects treated with Sodium Polystyrene Sulfonate (SPS; e.g. Kayexalate®) or ZS (microporous, fractionated, protonated zirconium silicate) within the last 30 days.
• Subjects with a life expectancy of less than 3 months.
• Subjects who are HIV positive.
• Subjects who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the subjects' tasks associated with the protocol.
• Women who are pregnant, lactating, or planning to become pregnant.
• Subjects with diabetic ketoacidosis.
• Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
• Known hypersensitivity or previous anaphylaxis to ZS or to components thereof.
• Previous treatment with SPS.
• Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
• Subjects with cardiac arrhythmias that require immediate treatment.
• Subjects on insulin where a stable dose has not yet been established.\*

Sponsors & Collaborators

• ZS Pharma, Inc.: lead

Study Sites (1)

Riverside Clinical Research

Edgewater, Florida, 32132, United States

Location

MeSH Terms

Conditions

Hyperkalemia

Interventions

polystyrene sulfonic acid

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Due to the high frequency of adverse events in the SPS group, the independent Data Monitoring Committee (iDMC) recommended termination of the study.

Results Point of Contact

• Title: Henrik Rasmussen, MD, PhD
• Organization: ZS Pharma, Inc

hrasmussen@zspharma.com

443-699-5230

Study Officials

• Henrik Rasmussen, MD

  ZS Pharma, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 31, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 3, 2014
• Results First Posted: September 3, 2014

Record last verified: 2014-08

Locations

US (1)