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

Primary Purpose

Hyperkalemia, Chronic Kidney Failure

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Sodium polystyrene sulfonate
Lactose with carob gum
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperkalemia focused on measuring Sodium Polystyrene Sulfonate, Kayexalate, Pre-dialysis, Outpatients, Hyperkalemia, Chronic kidney failure, Potassium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maisonneuve-Rosemont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sodium Polystyrene Sulfonate

Lactose with carob gum

Arm Description

30 g sodium polystyrene sulfonate powder, mixed with water qs ad 150 ml, taken PO once daily for seven days

30 g placebo powder, mixed with water qs ad 150 ml, taken PO once daily for seven days

Outcomes

Primary Outcome Measures

Change in serum potassium levels from baseline
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

Proportion of subjects attaining normokalemia (serum potassium level of 3.5 to 5.0 mmol/L) in each treatment arm
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
Number of patients with adverse events in each treatment group
Report the number of patients with adverse events, notably nausea, diarrhea, constipation, electrolyte disorders (hypomagnesemia, hypernatremia, hypophosphatemia, hypocalcemia, hypokalemia)

Full Information

First Posted
February 14, 2014
Last Updated
October 1, 2014
Sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT02065076
Brief Title
Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients
Acronym
SKIP
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Université de Montréal

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalemia, Chronic Kidney Failure
Keywords
Sodium Polystyrene Sulfonate, Kayexalate, Pre-dialysis, Outpatients, Hyperkalemia, Chronic kidney failure, Potassium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium Polystyrene Sulfonate
Arm Type
Active Comparator
Arm Description
30 g sodium polystyrene sulfonate powder, mixed with water qs ad 150 ml, taken PO once daily for seven days
Arm Title
Lactose with carob gum
Arm Type
Placebo Comparator
Arm Description
30 g placebo powder, mixed with water qs ad 150 ml, taken PO once daily for seven days
Intervention Type
Drug
Intervention Name(s)
Sodium polystyrene sulfonate
Other Intervention Name(s)
SPS, Kayexalate, Solystat
Intervention Type
Drug
Intervention Name(s)
Lactose with carob gum
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in serum potassium levels from baseline
Description
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
Time Frame
After 7 days
Secondary Outcome Measure Information:
Title
Proportion of subjects attaining normokalemia (serum potassium level of 3.5 to 5.0 mmol/L) in each treatment arm
Description
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
Time Frame
After 7 days
Title
Number of patients with adverse events in each treatment group
Description
Report the number of patients with adverse events, notably nausea, diarrhea, constipation, electrolyte disorders (hypomagnesemia, hypernatremia, hypophosphatemia, hypocalcemia, hypokalemia)
Time Frame
Up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Pichette, MD
Organizational Affiliation
Maisonneuve-Rosemont Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32588430
Citation
Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
Results Reference
derived

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

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