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  1. Development & Approval Process | Drugs

Drug Trials Snapshots: DEFENCATH

 

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic 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 healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the DEFENCATH Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

DEFENCATH (taurolidine 1.35% and heparin 5,000 Units/5 mL [1,000 Units/mL])
de fen’ kath
CorMedix Inc.
Original Approval date: November 15, 2023


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

DEFENCATH is a catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC).

How is this drug used?

DEFENCATH is a CLS that is instilled into each catheter lumen by a health care professional at the conclusion of each HD session for patients with kidney failure requiring chronic HD. Prior to initiation of the next HD session, it must be aspirated from the catheter and discarded.

Who participated in the clinical trials?

The FDA approved DEFENCATH based on evidence from a single clinical trial of 806 patients with kidney failure receiving HD therapy through a CVC. The trial was conducted at 60 sites in the United States.

How were the trials designed?

The benefits and side effects of AUGTYRO for patients with NSCLC that are ROS1-positive were evaluated in one clinical trial. Some patients were previously treated with a drug that inhibits ROS1 for their ROS1-positive NSCLC (pretreated subgroup) and some had not received prior treatment with a drug that inhibits ROS1 (treatment-naïve subgroup). All patients received AUGTYRO by mouth once daily for 14 days, then increased to 160 mg twice daily until either cancer progression or intolerable side effects.

The benefit of AUGTYRO was evaluated by measuring the percentage of patients who had complete or partial shrinkage of their tumors (overall response rate or ORR) and by measuring the duration of that benefit (duration of response or DOR).

How were the trials designed?

The benefit and side effects of DEFENCATH were evaluated in a single clinical trial of adult patients with kidney failure receiving chronic HD therapy through a CVC. Patients were randomly assigned to receive DEFENCATH or heparin as a CLS at the end of each HD session. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of DEFENCATH was assessed based on the rate of bloodstream infections, comparing patients in the DEFENCATH and heparin groups.


DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many male and female patients were in the clinical trial used to evaluate efficacy and safety.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 468 (58%) male patients and 338 (42%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes the percentage of patients by race in the clinical trial used to evaluate efficacy and safety.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, and other patients were in the clinical trial. In total, 510 (63%) White patients, 238 (29%) Black or African American patients, 33 (4%) Asian patients, 5 (1%) American Indian or Alaska Native, 14 (2%) Native Hawaiian or other Pacific Islander patients, and 6 (1%) other patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3 summarizes the percentage of patients by age enrolled in the clinical trial used to evaluate efficacy and safety.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 475 (59%) patients younger than 65 years of age and 331 (41%) patients 65 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes the percentage of patients by ethnicity enrolled in the clinical trial used to evaluate efficacy and safety.

Figure 4. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic and not Hispanic patients were in the clinical trial. In total, 366 (43%) Hispanic or Latino patients and 440 (57%) not Hispanic or Latino patients participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

Over the course of the study, patients treated with DEFENCATH as a CSL experienced fewer CRBSIs in comparison to patients who received heparin as a CSL.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age?

  • Sex: The observed effect of DEFENCATH was similar for females and males.
  • Race: DEFENCATH worked similarly in White and Black or African American patients. The number of patients in other races were limited; therefore, differences in how DEFENCATH worked among other races could not be determined.
  • Age: The observed effect of DEFENCATH was larger in patients older than 65 years of age than in patients younger than 65 years of age. Because of limited data, this difference may be due to chance.

What are the possible side effects?

The most common side effect was malfunctioning of the hemodialysis catheter. Other side effects include bleeding, low platelet count, nausea, vomiting, dizziness, and musculoskeletal chest pain.

Were there any differences in side effects among sex, race, and age?

  • Sex: The occurrence of side effects was similar in males and females.
  • Race: The majority of patients were White or Black or African American. The occurrence of hemodialysis catheter malfunction, vomiting, and hypertension was higher in the Black or African American subgroup. Because of limited data these differences may be due to chance.
  • Age: The occurrence of hemodialysis catheter malfunction was similar across all age groups. The ≥75-year-old age group had higher incidence of bleeding compared to the other age groups. Because of limited data this difference may be due to chance.

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.

PRESCRIBING INFORMATION

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