A new DRUG TRIALS SNAPSHOT is now available.
Drug Trials Snapshots: LOKELMA
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to LOKELMA Prescribing Information for complete information.
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to LOKELMA Prescribing Information for complete information.
LOKELMA (sodium zirconium cyclosilicate)
Lo-KELL-ma
AstraZeneca
Approval date: May 18,2018
Lo-KELL-ma
AstraZeneca
Approval date: May 18,2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
LOKELMA is a drug for the treatment of hyperkalemia in adults.
Hyperkalemia is a condition in which the amount of potassium in the blood is too high.
How is this drug used?
LOKELMA is a powder that is mixed with water and taken three times a day for up to 48 hours. For patients needing continued treatment, the drug is taken once a day, with the dose adjusted as needed based on the amount of potassium in the blood.
What are the benefits of this drug?
LOKELMA reduced high levels of potassium in the blood and maintained the potassium at a normal level.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: LOKELMA worked similarly in men and women.
- Race: LOKELMA worked similarly in White and Blacks or African American patients. The number of patients in other races was limited; therefore, differences in response to LOKELMA among all races could not be determined.
- Age: LOKELMA worked similarly in patients below and above 65 years of age.
What are the possible side effects?
The most common side effect of LOKELMA is body swelling because of its sodium content.
Were there any differences in side effects among sex, race and age?
- Sex: The risk of side effects was similar in men and women.
- Race: The risk of side effects was similar in White and Black or African American patients. The number of patients in other races was limited; therefore, differences in side effects among all races could not be determined.
- Age: The risk of side effects was similar in patients below and above 65 years of age.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved LOKELMA based primarily on evidence from two clinical trials (Trial 1 #NCT01737697 and Trial 2 #NCT02088073) of patients with hyperkalemia. The trials were conducted in the USA, Australia and South Africa.
The figure below summarizes how many men and women were in the clinical trials.
Figure 1. Baseline Demographics by Sex
Clinical Trial Data
Figure 2 and Table 1 below summarize the percentage of patients by race in the clinical trials.
Figure 2. Baseline Demographics by Race
Clinical Trial Data
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 859 | 85 |
| Black or African American | 124 | 12 |
| Asian | 17 | 2 |
| Native Hawaiian or other Pacific Islander | 6 | 1 |
| American Indian or Alaska Native | 4 | less than 1 |
| Multiple | 1 | less than 1 |
Clinical Trial Data
Figure 3 summarizes the percentage of patients by age enrolled in the clinical trials.
Figure 3. Baseline Demographics by Age
Clinical Trial Data
How were the trials designed?
The benefit and side effects of LOKELMA were evaluated in two clinical trials in patients with hyperkalemia. Each trial consisted of two parts.
In the first trial, patients with hyperkalemia received either LOKELMA at one of the four doses (1.25 g, 2.5 g, 5 g, or 10 g) or placebo three times a day for the first 48 hours. In the second part of the first trial, those patients who achieved normal potassium blood level received either LOKELMA at one of the four doses (1.25 g, 2.5 g, 5 g, or 10 g) or placebo once daily for 12 days. During the trial, neither the patients nor the health care providers knew which treatment was given.
In the second trial, all patients with hyperkalemia received 10 g of LOKELMA three times a day for the first 48 hours. In the second part of the trial, those patients who achieved normal potassium blood levels were randomized to one of three doses of LOKELMA administered once-daily for 28 days, or placebo. In this phase, neither patients not the health care providers knew which treatment was given.
The benefit of LOKELMA was assessed by measuring potassium level change over time and comparing it to placebo.
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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