CLINICAL TRIAL

Study Group for Infections

Waitlist Available · 18+ · All Sexes · Birmingham, AL

This study is evaluating whether Envarsus is as effective as Tacrolimus-IR in preventing BK virus infection.

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About the trial for Infections

Eligible Conditions
Communicable Diseases · Infections · Renal Transplant Infection

Treatment Groups

This trial involves 2 different treatments. Study Group is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Study Group
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Control Group
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
does not have increased overall mortality or reduced life expectancy Recipient of a deceased or living donor kidney transplantation does not have any increased overall mortality or reduced life expectancy. show original
is recommended for all patients with stable graft function I recommend that all patients with stable graft function take tacrolimus/ mycophenolate mofetil (MMF)/mycophenolic acid (MPA) (≥1000 mg/720 mg daily) ± prednisone (≤10 mg/day) for maintenance immunosuppression. show original
All women who are capable of becoming pregnant must review the Mycophenolate Risk Evaluation and Mitigation Strategy, and have a negative pregnancy test when they enter the study. show original
Female and male study participants who may become pregnant must agree to use a highly effective method of birth control throughout the study show original
The subject must be at least 18 years old when they start the study. show original
A patient has a tacrolimus dose/concentration of more than 1 with therapeutic tacrolimus levels. show original
The patient is less than or at 8 weeks post transplant and has had a negative serum BK Virus screen at 3-4 weeks post transplant. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From baseline to 300 days
Screening: ~3 weeks
Treatment: Varies
Reporting: From baseline to 300 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From baseline to 300 days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Study Group will improve 4 primary outcomes and 1 secondary outcome in patients with Infections. Measurement will happen over the course of From baseline to 300 days.

Participants will experience less BK infection episodes based on nephropathy results.
FROM BASELINE TO 300 DAYS
The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
FROM BASELINE TO 300 DAYS
Participants will experience less BK infection episodes based on viruria results.
FROM BASELINE TO 300 DAYS
The evidence of BK virus infection will be measured by viruria >500 copies.
FROM BASELINE TO 300 DAYS
Evaluate the effect of Envarsus conversion as evidenced by a 15% decrease in estimated glomerular filtration rate (GFR) and proteinuria.
FROM BASELINE TO 300 DAYS
This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria
FROM BASELINE TO 300 DAYS
Participants will experience less BK infection episodes based on viremia results.
FROM BASELINE TO 300 DAYS
The evidence of BK virus infection will be measured by viremia >500 copies.
FROM BASELINE TO 300 DAYS
Evaluate the safety of Envarsus treatment as assessed by CTCAE v4.0.
FROM BASELINE TO 300 DAYS
Safety will be assessed for all Grade 3 or higher infection
FROM BASELINE TO 300 DAYS

Who is running the study

Principal Investigator
G. C. T.
Graham C. Towns, Principal Investigator
University of Alabama at Birmingham

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can infections be cured?

At present, there is no cure for infections. The therapy for infections could not be perfected because the bacteria are too small to be seen and controlled by the human eye, even at the smallest magnification. However, it is possible to reduce the frequency of severe infections of the respiratory and urinary tracts with antibiotics when taken intermittently during the infection. The main problem of the antibiotic prophylaxis is the resistance of pathogenic bacteria. Although most frequently pathogenic bacteria are sensitive to the antibiotic medications, they are still able to be resisted. The antibiotics are effective against gram-positive bacteria, but rarely against gram-negative bacteria.

Anonymous Patient Answer

How many people get infections a year in the United States?

The number of infections that affect the United States population is a huge number and continues to increase in its population and complexity. Most commonly reported diseases are viral disease due to one or more of the following: common cold, hepatitis, gastroenteritis, respiratory illness, influenza, meningitis, encephalitis, and meningococcal disease. Of all infections, foodborne illness accounts for over 50% of reported illness with nearly 2...3 million cases per year. Foodborne illnesses are likely the leading cause of illness among those who have recently traveled to or resided in the United States. Other leading illnesses that may affect the public should be recognized by patients as other illnesses may be co-existent in those cases.

Anonymous Patient Answer

What is infections?

From a medical perspective, infections are frequently a cause of death. Severe or life-threatening infections cause about 15% of all deaths in developing countries. More than 150 kinds of pathogens are involved in infections, which generally occur worldwide. Severe or life-threatening infections are most frequent among the elderly, the infirm, the injured, patients with compromised immune systems, and patients with diabetes or renal dysfunction. A wide range of treatments are available and have become available over the past few decades. One in four new cases of life-threatening infections is prevented annually by public health measures, vaccines, and medical therapies. More than 20 new and more effective drugs for infections are under development.

Anonymous Patient Answer

What causes infections?

Individuals with chronic inflammatory or other chronic conditions are at increased risk of infections. Immunocompromised people are particularly prone to infection. There are several risk factors that contribute to an increased risk of infections, including increased age and chronic disorders.

Anonymous Patient Answer

What are the signs of infections?

An accurate knowledge of the signs and symptoms, in addition to a good physical examination, often leads to the timely recognition of infections and helps to treat them. The main signs of infections are fever, headache, nausea, vomiting, weight loss and night sweats. Routine follow-up of these signs enables early diagnosis and treatment.

Anonymous Patient Answer

What are common treatments for infections?

Given the common causes of the infections and recommendations by the AHRQ, clinicians should be aware of the most common treatments and be prepared for those that are uncommon so as to minimize antibiotic use and minimize potential adverse effects.

Anonymous Patient Answer

What is the latest research for infections?

The current available research has proven that [SARS] is the strongest risk to patients, and [SARS], [MERS] are the strongest risks to health professionals. Currently, infections only related to [SARS] and [MERS] were found, but they have some important facts we should read about. There are few infectious agents to choose such as [HIV]. [Graft versus host disease] refers to [HSV] and [VZV]. [Tuberculosis\nis found]. There are others such as [leishmaniasis]. The pathogens [syphilis] and [HIV] are mostly studied and reported by experts from all around the world, and it can be found online.

Anonymous Patient Answer

What is study group?

Group allocation can be a source of bias, especially in studies where the intervention may differ from its placebo according to a number of confounders, such as sex, age, disease duration, or other variables of interest.

Anonymous Patient Answer

Have there been other clinical trials involving study group?

Clinical trials are conducted across the globe and new drug development involves an ever-growing number of investigational therapies. In a recent study, findings highlights the importance of well-conducted and well reported clinical trials with patients and, where indicated, clinicaltrials.gov.

Anonymous Patient Answer

Who should consider clinical trials for infections?

Patients can understand the importance of clinical trials for infectious diseases when they are informed that they can expect a new treatment that will help them feel safer and healthier. In addition, patients who learn that they will be participating in a clinical trial can anticipate personal benefits including a chance to receive the safest or most effective treatment available for their illness/disease. Clinicians can use clinical trial information to inform patients about the advantages and disadvantages of a new treatment option before they have a chance to decide for themselves.

Anonymous Patient Answer

Does study group improve quality of life for those with infections?

Results from a recent paper indicate a statistically significant increase in quality of life across both the treatment groups at the end of the course of treatment. The improvements found for several dimensions of HRQoL are likely to be clinically significant.

Anonymous Patient Answer

Have there been any new discoveries for treating infections?

We cannot say there is new information worth searching because our results are not definitive. This means that we could find new information, but we do not find it worth spending the time and energy it would take to search for information. Although we could not find any one particular new discovery, that doesn’t mean it isn’t there. More specifically, it means these results could be used in a clinical trial to further advance treatment for people with infections.

Anonymous Patient Answer
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