Hyperkalemia Clinical Trial
— ENERGIZEOfficial title:
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ENERGIZE)
Verified date | January 2020 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 21, 2018 |
Est. primary completion date | December 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 130 Years |
Eligibility |
Inclusion Criteria: = 18 years of age Potassium =5.8 mmol/L Exclusion Criteria: Possible pseudohyperkalaemia Hyperkalaemia caused by any condition for which a therapy directed against the underlying cause of hyperkalaemia would be a better treatment option than treatment with insulin and glucose. Dialysis session expected within 4h after randomization Treated with any therapy intended to lower S-K between arriving at the hospital and randomization during Visit 1. |
Country | Name | City | State |
---|---|---|---|
Denmark | Research Site | Esbjerg | |
Denmark | Research Site | Herning | |
Italy | Research Site | Novara | |
Italy | Research Site | Piombino | |
Russian Federation | Research Site | Kemerovo | |
Russian Federation | Research Site | Kemerovo | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Perm | |
Russian Federation | Research Site | Ryazan | |
Russian Federation | Research Site | Saint-Petersburg | |
Russian Federation | Research Site | Yaroslavl | |
Russian Federation | Research Site | Yekaterinburg | |
United States | Research Site | Detroit | Michigan |
United States | Research Site | Detroit | Michigan |
United States | Research Site | Detroit | Michigan |
United States | Research Site | Durham | North Carolina |
United States | Research Site | El Paso | Texas |
United States | Research Site | Houston | Texas |
United States | Research Site | Montgomery | Alabama |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Royal Oak | Michigan |
United States | Research Site | Saint Louis | Missouri |
United States | Research Site | Stony Brook | New York |
United States | Research Site | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Denmark, Italy, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Absolute Change in S-K From Baseline Until 4h 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. | Baseline to 4h potassium measurements. | |
Secondary | 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 | 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. | Baseline to 4h potassium meansurements. | |
Secondary | The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo | Proportion of patients achieving normokalaemia, S-K 3.5-5.0 mmol/L, at 1, 2 and 4h after start of dosing | Baseline to 4h potassium meansurements. | |
Secondary | The Fraction of Patients Achieving S-K <5.5mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo | Baseline to 4h potassium meansurements. | ||
Secondary | The Fraction of Patients Achieving S-K <6.0mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo | Baseline to 4h potassium meansurements. | ||
Secondary | The Fraction of Patients Administered Additional Potassium Lowering Therapy Due to Hyperkalaemia From 0 to 4h. | 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. | Baseline to 4h potassium meansurements. | |
Secondary | 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 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. | Baseline to 2h potassium measurements. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03172702 -
Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
|
Phase 3 | |
Terminated |
NCT05056727 -
A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
|
Phase 3 | |
Recruiting |
NCT05766839 -
Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
|
Phase 2 | |
Completed |
NCT02609841 -
POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study
|
N/A | |
Recruiting |
NCT06277128 -
A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia.
|
Phase 2 | |
Recruiting |
NCT04789239 -
OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure
|
Phase 2 | |
Completed |
NCT05029310 -
Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients
|
Phase 4 | |
Terminated |
NCT04443608 -
Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management
|
Phase 4 | |
Completed |
NCT02607085 -
REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: Multicenter, Prospective, Observational Study
|
N/A | |
Completed |
NCT03283267 -
A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
|
Phase 1 | |
Recruiting |
NCT06036823 -
5 Versus 10 Units of Insulin in Hyperkalemia Management
|
Phase 4 | |
Recruiting |
NCT05173584 -
Levalbuterol Compared to Albuterol Regarding Cardiac Side Effects and Potassium Lowering Effects.
|
Phase 4 | |
Completed |
NCT05184998 -
Description of the Clinical Outcomes of Hospitalized Patients With Heart Failure With Different Serum Potassium Levels
|
||
Completed |
NCT01737697 -
Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia
|
Phase 3 | |
Completed |
NCT01493024 -
Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia
|
Phase 2 | |
Completed |
NCT04207203 -
Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study
|
N/A | |
Completed |
NCT05382988 -
Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy
|
Phase 3 | |
Completed |
NCT04217590 -
Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
|
Phase 3 | |
Recruiting |
NCT03096561 -
Measurement of Serum Potassium Rate During Accidental Hypothermia.
|
N/A | |
Completed |
NCT03326583 -
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
|
Phase 2 |