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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:
Collaborators:
Nephrology Research Axis of Maisonneuve Rosemont Hospital
Université de Montréal
Department of Pharmacy, Maisonneuve Rosemont Hospital
Information provided by (Responsible Party):
Dr. Vincent Pichette, Maisonneuve-Rosemont Hospital

Tracking Information
First Submitted Date  ICMJE February 14, 2014
First Posted Date  ICMJE February 17, 2014
Last Update Posted Date October 3, 2014
Study Start Date  ICMJE February 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02065076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2014)
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • Proportion of subjects attaining normokalemia (serum potassium level of 3.5 to 5.5 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 5.5 mmol/L) in each arm after one week of sodium polystyrene sulfonate or placebo
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients
Official Title  ICMJE Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Ambulatory Pre-dialysis Outpatients : a Randomized Triple-blind Placebo-controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperkalemia
  • Chronic Kidney Failure
Intervention  ICMJE
  • Drug: Sodium polystyrene sulfonate
    Other Names:
    • SPS
    • Kayexalate
    • Solystat
  • Drug: Lactose with carob gum
    Other Name: Placebo
Study Arms  ICMJE
  • 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
    Intervention: Drug: Sodium polystyrene sulfonate
  • Placebo Comparator: Lactose with carob gum
    30 g placebo powder, mixed with water qs ad 150 ml, taken PO once daily for seven days
    Intervention: Drug: Lactose with carob gum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 14, 2014)
38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02065076
Other Study ID Numbers  ICMJE 13089
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Vincent Pichette, Maisonneuve-Rosemont Hospital
Study Sponsor  ICMJE Maisonneuve-Rosemont Hospital
Collaborators  ICMJE
  • Nephrology Research Axis of Maisonneuve Rosemont Hospital
  • Université de Montréal
  • Department of Pharmacy, Maisonneuve Rosemont Hospital
Investigators  ICMJE
Principal Investigator: Vincent Pichette, MD Maisonneuve-Rosemont Hospital
PRS Account Maisonneuve-Rosemont Hospital
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP