HyperkalemiaPhase 4SKIPNCT02065076
Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients
A Phase 4 study testing Sodium polystyrene sulfonate and Lactose with carob gum in people with Hyperkalemia and Chronic Kidney Failure, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia, Chronic Kidney Failure
- What is being tested?
- Sodium polystyrene sulfonate and Lactose with carob gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Ambulatory Pre-dialysis Outpatients : a Randomized Triple-blind Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Hyperkalemia, Chronic Kidney Failure
- Being tested
- Sodium polystyrene sulfonate, Lactose with carob gum
- Keywords
- Sodium Polystyrene Sulfonate, Kayexalate, Pre-dialysis, Outpatients, Hyperkalemia, Chronic kidney failure, Potassium
- Medical subject headings
- Hyperkalemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium polystyrene sulfonateDrug
Also called SPS, Kayexalate, Solystat
Lactose with carob gumDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Lactose with carob gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: After 7 days
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)
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Principal investigator, Dr. Vincent Pichette, Maisonneuve-Rosemont Hospital
- Investigators
- Vincent Pichette, MD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065076
- Sponsor's protocol ID
- 13089
- Acronym
- SKIP
- Status last verified
- Oct 2014
- First submitted
- 14 Feb 2014
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32588430
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Ambulatory Pre-dialysis Outpatients : a Randomized Triple-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02065076
- Acronym / sponsor ID
- SKIP / 13089
- Conditions
- Hyperkalemia, Chronic Kidney Failure
- Keywords
- Sodium Polystyrene Sulfonate, Kayexalate, Pre-dialysis, Outpatients, Hyperkalemia, Chronic kidney failure, Potassium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Polystyrene Sulfonate | Active comparator | Drug: Sodium polystyrene sulfonate30 g sodium polystyrene sulfonate powder, mixed with water qs ad 150 ml, taken PO once daily for seven days |
| Lactose with carob gum | Placebo comparator | Drug: Lactose with carob gum30 g placebo powder, mixed with water qs ad 150 ml, taken PO once daily for seven days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium polystyrene sulfonateAlso: SPS, Kayexalate, Solystat | Drug | Sodium Polystyrene Sulfonate |
| Lactose with carob gumAlso: Placebo | Drug | Lactose with carob gum |
Primary outcome
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
2 secondary outcomes
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
Number of patients with adverse events in each treatment group
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
- Derived from this study: PubMed 32588430Natale 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.
Related trials for Hyperkalemia
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
RecruitingPhase 3
A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Pichette, MD principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium polystyrene sulfonate and Lactose with carob gum in people with Hyperkalemia and Chronic Kidney Failure, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum potassium levels from baseline (time frame: After 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02065076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.