| Trial ID: | L1149 |
| Source ID: | NCT02065076
|
| Associated Drug: |
Sodium Polystyrene Sulfonate
|
| Title: |
Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients
|
| Acronym: |
SKIP
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperkalemia|Chronic Kidney Failure
|
| Interventions: |
DRUG: Sodium polystyrene sulfonate|DRUG: Lactose with carob gum
|
| Outcome Measures: |
Primary: 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: 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, 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), Up to 7 days
|
| Sponsor/Collaborators: |
Sponsor: Maisonneuve-Rosemont Hospital | Collaborators: Université de Montréal
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
38
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-02
|
| Completion Date: |
2014-10
|
| Results First Posted: |
|
| Last Update Posted: |
2014-10-03
|
| Locations: |
Maisonneuve-Rosemont Hospital, Montreal, Quebec, H1T 2M4, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02065076
|
