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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maisonneuve-Rosemont Hospital
• Collaborators: Department of Pharmacy, Maisonneuve Rosemont Hospital; Nephrology Research Axis of Maisonneuve Rosemont Hospital; Université de Montréal
• Treatments: Polystyrene sulfonic acid

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