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Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients (SKIP)

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ClinicalTrials.gov Identifier: NCT02065076
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : October 3, 2014
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
Dr. Vincent Pichette, Maisonneuve-Rosemont Hospital

Study Description
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Brief Summary:
The purpose of this trial is to determine if sodium polystyrene sulfonate (SPS) is an effective treatment of mild hyperkalemia in chronic kidney disease patients followed at a pre-dialysis or nephrology outpatient clinic. Subjects will be randomized to one of two treatment arms: 30 g of placebo or SPS to be taken orally once daily for seven days. The change in serum potassium levels will be compared in both treatment groups. The proportion of subjects attaining normokalemia (3.5 to 5.0 mmol/L) after seven days of treatment will also be compared. Finally, side effects will be reported for each treatment arm.

Condition or disease Intervention/treatment Phase
Hyperkalemia Chronic Kidney Failure Drug: Sodium polystyrene sulfonate Drug: Lactose with carob gum Phase 4

Detailed Description:

Background

Hyperkalemia affects up to 10% of patients suffering from chronic kidney failure and up to 42% of patients with an estimated glomerular filtration rate lower than 20 mL/min/1.73m2. There is currently limited evidence on the use of sodium polystyrene sulfonate for the treatment of mild hyperkalemia. There are even fewer trials supporting its use over several days. To our knowledge, only one other study has evaluated its chronic use in fourteen patients, but hadn't controlled for recent changes in medications. Since its use is associated with adverse events that can considerably affect patients' quality of life, it appears primordial to better assess its place in the treatment of hyperkalemia in pre-dialysis patients.

Methods

The aim of this trial is to evaluate the use of sodium polystyrene sulfonate in the treatment of mild asymptomatic hyperkalemia in predialysis patients. Participants will be randomized to receive either 30 g of placebo or 30 g of SPS orally once daily for seven days. Serum potassium levels will be assessed at baseline and on the day following the last dose of their treatment. The change in serum potassium levels and the proportion of patients attaining normokalemia will be compared between study groups. The incidence of adverse events (nausea, diarrhea, constipation, electrolyte disorders) will also be reported. Participants will also be asked to fill out a food diary for 3 out of the 7 study days. This diary will be used to estimate each participant's average daily intake of potassium and therefore evaluate the similarity of diets between both intervention arms.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Ambulatory Pre-dialysis Outpatients : a Randomized Triple-blind Placebo-controlled Trial
Study Start Date : February 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Potassium

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sodium Polystyrene Sulfonate
30 g sodium polystyrene sulfonate powder, mixed with water qs ad 150 ml, taken PO once daily for seven days
 Drug: Sodium polystyrene sulfonate
Other Names:
  • SPS
  • Kayexalate
  • Solystat
Placebo Comparator: Lactose with carob gum
30 g placebo powder, mixed with water qs ad 150 ml, taken PO once daily for seven days
 Drug: Lactose with carob gum
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in serum potassium levels from baseline [ Time Frame: After 7 days ]
    Compare the change in serum potassium levels from baseline in both treatment arms after 7 days of treatment with SPS or placebo 30 g once daily


Secondary Outcome Measures :
  1. Proportion of subjects attaining normokalemia (serum potassium level of 3.5 to 5.0 mmol/L) in each treatment arm [ Time Frame: After 7 days ]
    Compare the proportion of subjects attaining normokalemia (serum potassium level of 3.5 to 5.0 mmol/L) in each arm after one week of sodium polystyrene sulfonate or placebo

  2. Number of patients with adverse events in each treatment group [ Time Frame: Up to 7 days ]
    Report the number of patients with adverse events, notably nausea, diarrhea, constipation, electrolyte disorders (hypomagnesemia, hypernatremia, hypophosphatemia, hypocalcemia, hypokalemia)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years and over
  • Outpatients followed at the pre-dialysis or nephrology clinics of Maisonneuve-Rosemont Hospital
  • Subjects who have taken SPS in the past 7 days: serum potassium level measured for their regular followup of 4.5 to 5.5 mmol/L, inclusive, and serum potassium level of 5.0 to 5.9 mmol/L, inclusive, after a one week washout period
  • Subjects who have not taken SPS in the past 7 days: serum potassium levels measured for their regular followup and on the day of randomisation of 5.0 to 5.9, inclusive

Exclusion Criteria:

  • Subjects with a contraindication to SPS : known hypersensitivity to the product, history of obstructive bowel disease, patients at high risk of obstructive bowel disease
  • Subjects unable of giving informed consent
  • Subjects with severe or symptomatic hyperkalemia requiring a treatment
  • Subjects on dialysis (hemodialysis or peritoneal dialysis)
  • Women who are pregnant or breastfeeding
  • Subjects who have had a change in the dosage of insulin in the past week, if this change represents more than 10% of the daily total dose or more than 5 units
  • Subjects who stopped, started or changed the dosage of an angiotensin converting enzyme inhibitor, an angiotensin II receptor blocker or aliskiren in the past 60 days
  • Subjects who stopped, started or changed the dosage of another medication affecting serum potassium levels in the past 30 days
  • Subjects who have had an episode of decompensated heart failure in the past 30 days
  • Subjects currently enrolled on another research protocol
  • Subjects who are lactose intolerant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065076


Locations
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Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Université de Montréal
Investigators
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Principal Investigator: Vincent Pichette, MD Maisonneuve-Rosemont Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Vincent Pichette, M.D., Ph.D., FRCP(C), nephrologist, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT02065076    
Other Study ID Numbers: 13089
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: October 2014
Keywords provided by Dr. Vincent Pichette, Maisonneuve-Rosemont Hospital:
Sodium Polystyrene Sulfonate
Kayexalate
Pre-dialysis
Outpatients
 Hyperkalemia
Chronic kidney failure
Potassium
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Hyperkalemia
Kidney Diseases
Urologic Diseases
Water-Electrolyte Imbalance
 Metabolic Diseases
Renal Insufficiency, Chronic
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action