Trial Outcomes & Findings for Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia (NCT NCT04997161)
NCT ID: NCT04997161
Last Updated: 2023-01-19
Results Overview
Change in serum potassium taken at long interdialytic-dialysis interval visits Month 3, Month 4, and Month 5 compared to baseline
TERMINATED
PHASE4
3 participants
Baseline to Month 5
2023-01-19
Participant Flow
One participant was randomised prior to study termination by sponsor
Participant milestones
| Measure |
Overall Study
All enrolled participants
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
Randomized
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Overall Study
All enrolled participants
|
|---|---|
|
Overall Study
Study terminated by sponsor
|
3
|
Baseline Characteristics
test
Baseline characteristics by cohort
| Measure |
Randomized Participants
n=1 Participants
All randomized participants
|
|---|---|
|
Age, Categorical
<=18 years
|
NA Participants
n=5 Participants • test
|
|
Age, Categorical
Between 18 and 65 years
|
NA Participants
n=5 Participants • test
|
|
Age, Categorical
>=65 years
|
NA Participants
n=5 Participants • test
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 5Population: Data were not collected as the study closed prior to the pre-specified Time Frame for analysis.
Change in serum potassium taken at long interdialytic-dialysis interval visits Month 3, Month 4, and Month 5 compared to baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 2 to Month 5Population: Data were not collected as the study closed prior to the pre-specified Time Frame for analysis.
Change from baseline in fruit and vegetable consumption determined by participant-reported intake using Noom app from Month 2 to Month 5
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study start to study endPopulation: Data were not collected due to study early termination.
Electronic versions of the following: Kidney Disease and Quality of Life-36 item (KDQOL-36; symptoms/problems, Physical Component Summary and Mental Component Summary, Burden of Kidney Disease and Effects of Kidney Disease) EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Abbreviated Treatment Satisfaction Questionnaire for Medication (9 items) (TSQM-9) Patients' Global Impression of Change (PGIC)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study start to study endPopulation: Data were not collected as the study closed prior to the pre-specified Time Frame for analysis.
Effect of the combination of sodium zirconium cyclosilicate and enhanced nutritional advice to consume fruit and vegetables as compared to standard of care in maintaining serum potassium levels within a range of 3.5 to 5.5 mmol/L, without requiring rescue therapy for hyperkalaemia. Binary response (responder/non-responder) with criteria that at least 66% of serum potassium values taken at long interdialytic-dialysis interval visits in Months 3, 4, and 5 fall between 3.5 and 5.5 mmol/L. Receiving rescue therapy or a potassium binder for hyperkalaemia during the final 3 months of the study was to result in a non-response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study start to study endPopulation: Data were not collected due to study early termination.
Safety and tolerability were to be evaluated in terms of adverse events (AEs), vital signs, clinical laboratory, interdialytic weight gain, and electrocardiograms. Assessments related to AEs covered occurrence/frequency, relationship to sodium zirconium cyclosilicate as assessed by Investigator, intensity, seriousness, death, and AEs leading to discontinuation of sodium zirconium cyclosilicate.
Outcome measures
Outcome data not reported
Adverse Events
Randomized Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years of completion of the Study shall require the Sponsor's prior written consent. The Investigator will provide the Sponsor with copies of any materials relating to the study or developed technologies that they intend to publish or present at least 30 days in advance of publication, submission, or presentation.
- Publication restrictions are in place
Restriction type: OTHER