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

NCT02065076 | Completed Phase 4

• 1 other identifier: 13089
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperkalemia; Chronic Kidney Failure

Keywords

Sodium Polystyrene Sulfonate; Kayexalate; Pre-dialysis; Outpatients; Hyperkalemia; Chronic kidney failure; Potassium

Outcome Measures

Primary Outcomes (1)

• 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

  After 7 days

Secondary Outcomes (2)

• Proportion of subjects attaining normokalemia (serum potassium level of 3.5 to 5.0 mmol/L) in each treatment arm

  After 7 days

• Number of patients with adverse events in each treatment group

  Up to 7 days

Study Arms (2)

Sodium Polystyrene Sulfonate

ACTIVE COMPARATOR

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

Drug: Sodium polystyrene sulfonate

Lactose with carob gum

PLACEBO COMPARATOR

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

Drug: Lactose with carob gum

Interventions

Sodium polystyrene sulfonate DRUG

Also known as: SPS, Kayexalate, Solystat

Sodium Polystyrene Sulfonate

Lactose with carob gum DRUG

Also known as: Placebo

Lactose with carob gum

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• Université de Montréal: collaborator

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (1)

• 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.

  PMID: 32588430 DERIVED

MeSH Terms

Conditions

Hyperkalemia; Kidney Failure, Chronic

Interventions

polystyrene sulfonic acid; Lactose

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Vincent Pichette, MD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., FRCP(C), nephrologist

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

CA (1)