CLINICAL TRIAL

Everolimus for Kidney Failure

Recruiting · 18+ · All Sexes · Indianapolis, IN

Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function

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About the trial for Kidney Failure

Eligible Conditions
Renal Insufficiency · Kidney Failure

Treatment Groups

This trial involves 2 different treatments. Everolimus 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 3 and have had some early promising results.

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

About The Treatment

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

Side Effect Profile for Standard of Care

Standard of Care
Show all side effects
20%
Immunosuppression held or modified
20%
Hospitalization
10%
Infections
Immunosuppression held or modified
20%
Hospitalization
20%
Infections
10%
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02096107) in the Standard of Care ARM group. Side effects include: Immunosuppression held or modified with 20%, Hospitalization with 20%, Infections with 10%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Liver transplant recipients ≥ 18 years old
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Candidates for liver transplantation include those with ethanol-associated liver disease, hepatitis C, and nonalcoholic steatohepatitis. show original
Baseline renal dysfunction (GFR ≤ 60 mL/min)
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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: 36 Months
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 Months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 36 Months.
View detailed reporting requirements
Trial Expert
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- 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 Everolimus will improve 3 primary outcomes in patients with Kidney Failure. Measurement will happen over the course of 36 Months.

Glomerular Filtration Rate in Patients treated with Everolimus
36 MONTHS
Glomerular Filtration Rate
36 MONTHS
Glomerular Filtration Rate in Patients treated with Tacrolimus
36 MONTHS
Glomerular Filtration Rate
36 MONTHS
Number of Patients Who Experience Transplant Rejection
36 MONTHS
Biopsy
36 MONTHS

Who is running the study

Principal Investigator
C. K.
Chandrashekhar Kubal, Principal Investigator
Indiana University

Patient Q & A Section

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

What is everolimus?

The safety of everolimus in subjects with ESRD and no history of heart failure was demonstrated in this large prospective safety study. Prospective studies are ongoing to assess everolimus long-term safety in subjects with ESRD and heart failure.

Anonymous Patient Answer

Can kidney failure be cured?

As CKD progresses, dialysis is often initiated. In dialysis patients, many non-treatable factors such as inflammation, hypertension, and underlying vascular disease contribute to poor cardiovascular health and accelerated atherosclerotic disease, a risk factor of CKD progression. Treating these non-treatable underlying vascular diseases can help delay, reduce and improve the progression of CKD in dialyzed patients.

Anonymous Patient Answer

What are the signs of kidney failure?

The signs of kidney failure are: blood in the urine, tiredness or feeling tired, confusion and feeling dizzy. Pain and itch may also occur - especially in people with end-stage kidney failure. There may be a lack of appetite and feeling of unwellness. It is likely that other diseases are also associated with kidney failure. A urine test should be done to check if the cause is kidney failure and to provide the clinician with information and advice about treatment.

Anonymous Patient Answer

What is kidney failure?

Kidney failure is a situation which has emerged from the failure of the kidneys to produce the body's normal volume of urine as waste products build up. This results in the urinary system having to reabsorb water and a volume of fluid from the bloodstream.\n

Anonymous Patient Answer

What causes kidney failure?

Recent findings shows that kidney failure is not a result of the presence of chronic nephropathy but is caused by a failure of the nephrons to excrete urea, which leads to increased urea levels that damage the glomeruli. Recent findings have implications for the search and management of the cause for nephropathy, as we propose that the disorder of the kidney cells themselves may be a key factor.

Anonymous Patient Answer

How many people get kidney failure a year in the United States?

There are around 990,000 people in the United States each year who require dialysis. By contrast, around 1.2 million people are estimated to die from kidney failure in the United States.

Anonymous Patient Answer

What are common treatments for kidney failure?

People with chronic kidney failure often receive dialysis and are prescribed a range of medications, including antihypertensives, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) and statins. A wide variety of supplements are also used in the treatment of chronic kidney failure in the European Union, but the effectiveness of the available evidence is not clear.

Anonymous Patient Answer

What are the common side effects of everolimus?

Although no severe side effects were observed in this study, everolimus should be used cautiously in patients with renal impairment and congestive heart failure or patients with diabetes mellitus or renal impairment or congestive heart failure.

Anonymous Patient Answer

Has everolimus proven to be more effective than a placebo?

Everolimus seems safe and effective for the long-term management of diabetic nephropathy in adults with type 2 diabetes. Given its low rate of adverse effects, it could replace calcineurin inhibitors as the therapy of choice in patients with type 2 diabetes and diabetic nephropathy.

Anonymous Patient Answer

What is the primary cause of kidney failure?

CKD is a heterogeneous disease, of which at least 4 different etiologies are likely to be identified with more advanced stages of disease. For instance, the glomerulonephritic pathology seen in the absence of focal loss has not yet been identified in the primary kidney disease literature. We believe more study will result in a greater understanding of the genetic and immune factors that contribute to kidney pathology and progression.

Anonymous Patient Answer

Does kidney failure run in families?

The prevalence of kidney failure seems to be associated with family history. We suggest that kidney disease should be a high-priority component for the prenatal screening of families in which kidney disease is a hereditary disease.

Anonymous Patient Answer

What is the average age someone gets kidney failure?

There is an increasing prevalence of kidney failure in Sweden which is worrying and needs urgent attention. Furthermore, the age at diagnosis is older. This may be a consequence of earlier nephrology treatment of patients with proteinuria, leading to earlier diagnosis of kidney failure.

Anonymous Patient Answer
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