EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

ZS will be administered in addition to insulin and glucose. Insulin and glucose is the current standard of care to treat serum potassium ≥5.8mmol/L.

Placebo will be administered in addition to insulin and glucose. Insulin and glucose is the current standard of care to treat serum potassium ≥5.8mmol/L.

The study is designed to determine if ZS 10g administered up to three times over 10h added to insulin and glucose in patients presenting with hyperkalemia will prove tolerable and efficacious. Patients will receive ZS or Placebo on top of standard of care treatment with insulin and glucose.

A study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) among patients with S-K ≥5.8

NCT ID

Patient Level Data

Therapeutic Area

Suspension administered orally for a treatment period of 24h. 2 sachets administered up to three times over 10h (at 0, 4 and 10h).

Suspension administered orally for a treatment period of 24h. Single dose contains 2 sachets of ZS 5g. 10g administered up to three times over 10h (at 0, 4 and 10h).

Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.

Glucose 25g administered IV <15 minutes before the insulin.

Research Site

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study
to Evaluate a Potassium Normalization Treatment Regimen Including Sodium
Zirconium Cyclosilicate (ENERGIZE)

To assess the effect of ZS vs placebo when added to insulin and glucose on the reduction of potassium at 4 hours after start of dosing

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Region of Enrollment

Age, Customized

Recruitment was stopped at 70 patients randomized instead of 132, as initially planned.

Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K. Patients with any missing potassium value from 1h to 4h inclusive will be treated as non-responders.

Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.

Fraction of patients responding to therapy defined as: S-K <6.0mmol/L between 1 and 4h and S-K <5.0mmol/L at 4h; and no additional potassium lowering therapy from 0 to 4h with exception of the initial insulin treatment

Proportion of patients achieving normokalaemia, S-K 3.5-5.0 mmol/L, at 1, 2 and 4h after start of dosing

The fraction of patients achieving normokalaemia 1, 2 and 4h after start of dosing with SZC/placebo

The fraction of patients achieving S-K <5.5mmol/l 1, 2, and 4h after start of dosing with SZC/placebo

The fraction of patients achieving S-K <6.0mmol/l 1, 2, and 4h after start of dosing with SZC/placebo

Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K.

The fraction of patients administered additional potassium lowering therapy due to hyperkalaemia from 0 to 4h.

The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 1h and 2h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.

Mean absolute change in S-K from baseline to 1h and 2h after start of dosing with SZC/placebo

The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 4h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.

Mean absolute change in S-K from baseline until 4h after start of dosing with SZC/placebo

Overall Study

Patients with S-K ≥5.8 mmol/L for whom treatment with insulin and glucose to manage hyperkalaemia has been determined medically appropriate by the Investigator. The study originally recruited patients with S-K ≥6.0 mmol/L; however, this inclusion criterion was updated during CSP Amendment to allow enrolment of patients with S-K ≥5.8 mmol/L.

Study Information Center

To assess the effect of ZS vs placebo when added to insulin and glucose on the response to therapy

To assess the effect of ZS vs placebo when added to insulin and glucose on the change in serum potassium at 1h and 2h after start of dosing

To assess the effect of ZS vs placebo when added to insulin and glucose on achieving normokalaemia

To assess the effect of ZS vs placebo when added to insulin and glucose on achieving S-K <5.5mmol/l and <6.0mmol/l

To assess the need for additional therapies for hyperkalaemia between ZS and placebo when added to insulin and glucose

Arms	Assigned Interventions
Experimental: ZS+insulin+glucose ZS will be administered in addition to insulin and glucose. Insulin and glucose is the current standard of care to treat serum potassium ≥5.8mmol/L.	Drug: Sodium Zirconium Cyclosilicate(ZS) Suspension administered orally for a treatment period of 24h. Single dose contains 2 sachets of ZS 5g. 10g administered up to three times over 10h (at 0, 4 and 10h). Other Name: ZS, ZS-9 Drug: Insulin Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes. Drug: Glucose Glucose 25g administered IV <15 minutes before the insulin.
Placebo Comparator: Placebo+insulin+glucose Placebo will be administered in addition to insulin and glucose. Insulin and glucose is the current standard of care to treat serum potassium ≥5.8mmol/L.	Drug: Placebo Suspension administered orally for a treatment period of 24h. 2 sachets administered up to three times over 10h (at 0, 4 and 10h). Drug: Insulin Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes. Drug: Glucose Glucose 25g administered IV <15 minutes before the insulin.

A study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) among patients with S-K ≥5.8 - ENERGIZE

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

CSP_redacted_version

SAP_redacted_version

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator