CLINICAL TRIAL

tolebrutinib for Kidney Failure

Recruiting · 18+ · All Sexes · Miami, FL

Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants

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About the trial for Kidney Failure

Eligible Conditions
Renal Insufficiency · deteriorating renal function

Treatment Groups

This trial involves 3 different treatments. Tolebrutinib is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
tolebrutinib
DRUG
Experimental Group 2
tolebrutinib
DRUG
Experimental Group 3
tolebrutinib
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
For participants with severe RI (Part A): Absolute GFR <30 mL/min, and not requiring dialysis (based on estimated glomerular filtration rate [eGFR] by absolute GFR from the MDRD formula with individual BSA, without race correction), with a variability within +/- 20% between screening and Day -1 assessments.
For participants with moderate RI (Part B conditional): 30 mL/min ≤ absolute GFR ≤59 mL/min (based on estimated glomerular filtration rate [eGFR] by absolute GFR from the MDRD formula with individual body surface area (BSA), without race correction), with a variability within +/- 20% between screening and Day -1 assessments
For participants with normal renal function: Absolute GFR ≥ 90 mL/min (based on eGFR by absolute GFR from the MDRD formula with individual BSA, without race correction), with a variability within +/- 20% between screening and Day -1 assessments.
Body weight between 50.0- and 115.0 kg, inclusive, if male, between 40.0 and 100 kg, inclusive, if female, and body mass index (BMI) between 18 to 40 kg/m2 inclusive, at screening.
You have a platelet count of 150,000 or more. 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 Day 1 to Day 8
Screening: ~3 weeks
Treatment: Varies
Reporting: From Day 1 to Day 8
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From Day 1 to Day 8.
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 tolebrutinib will improve 2 primary outcomes and 5 secondary outcomes in patients with Kidney Failure. Measurement will happen over the course of From Day 1 to Day 4.

Assessment of PK parameters Tolebrutinib: AUClast
FROM DAY 1 TO DAY 4
Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to the real time AUClast
FROM DAY 1 TO DAY 4
Assessment of PK parameters M2: AUC
FROM DAY 1 TO DAY 4
FROM DAY 1 TO DAY 4
Assessment of PK parameters Tolebrutinib: AUC
FROM DAY 1 TO DAY 4
Area under the plasma concentration (AUC) versus time curve extrapolated to infinity
FROM DAY 1 TO DAY 4
Assessment of PK parameters M2: AUClast
FROM DAY 1 TO DAY 4
FROM DAY 1 TO DAY 4
Assessment of PK parameters Tolebrutinib: Cmax
FROM DAY 1 TO DAY 4
Maximum plasma concentration observed (Cmax)
FROM DAY 1 TO DAY 4
Assessment of PK parameters M2: Cmax
FROM DAY 1 TO DAY 4
FROM DAY 1 TO DAY 4
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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 are common treatments for deteriorating renal function?

The majority of patients (96%) with renal insufficiency at the time of dialysis initiation (compared to those with normal renal function) receive ACEI or ARB at the time of dialysis initiation. ACEI or ARB is the primary agent for improving survival and preventing progression of chronic kidney disease in both renal insufficiency groups. ARBs may be more effective than ACEI in patients with renal insufficiency (and advanced chronic kidney disease) in preventing progression of chronic kidney disease at the initial time of dialysis initiation. We postulate that this difference in benefit may result from higher plasma concentrations of ARB, possibly attributable to poor absorption.

Anonymous Patient Answer

What is deteriorating renal function?

Patients with the most severe type of CKD have decreased survival. They are older and have more comorbid conditions and more advanced dialysis dependence and comorbidities when they enter the kidney replacement program. Better understanding of the underlying mechanisms and therapies are warranted to provide the optimal treatment for these patients and their families.

Anonymous Patient Answer

How many people get deteriorating renal function a year in the United States?

The number of people with declining renal function continues to be increasing, although current trends seem to be slowing. The cause of this slowing trend is not clear and warrants further study.

Anonymous Patient Answer

What causes deteriorating renal function?

The common denominator underlying chronic kidney disease is an increase in glomerular filtration rate. The causes of this increase can vary from simple ageing to more complex metabolic disease that include a range of risk factors, such as hypertension, diabetes and excess weight. This in turn, predisposes to albuminuria, proteinuria or diabetic nephropathy. Over time the damage that affects other organs of chronic kidney disease causes the kidney to become a target organ by itself, as illustrated by the development of kidney cancer.

Anonymous Patient Answer

What are the signs of deteriorating renal function?

We found signs of deterioration of renal function in our study. The severity of renal dysfunction was similar to that of the general population. It can be associated with multiple causes (e.g., proteinuria, glomerular filtration impairment, high urinary albumin excretion or metabolic syndrome). More work is needed to establish a standard definition of renal impairment.

Anonymous Patient Answer

Can deteriorating renal function be cured?

When renal function is seriously impaired, dialysis or hemodialysis can only slow the decline of renal function and improve the patient's quality of life. However, some patients with worsening renal function may benefit from aggressive interventions in the form of peritoneal dialysis or renal transplantation.

Anonymous Patient Answer

What is the latest research for deteriorating renal function?

The kidney is a key organ involved in protein metabolism and plays a vital role in maintaining blood pressure. The kidney deteriorates from a chronic or sudden loss of proteins. Once the kidney stops working, it can become a life-threatening condition. Kidney failure can occur in both acute or chronic kidney diseases. Dialysis and kidney transplant are the two treatment options available to patients with end-stages of kidney failure. In the United States, one out of three patients have end-stages of kidney failure, [over a lifetime] with women being more likely to develop end-stage kidney failure in comparison to men. Women were also three times as likely to need to initiate hemodialysis in comparison to men.

Anonymous Patient Answer

Does tolebrutinib improve quality of life for those with deteriorating renal function?

This subgroup of patients had worse health-related quality of life before tolebrutinib therapy, but there was no worsening after either time points tested. Treatment with tolebrutinib was tolerated by most patients who experienced progressive renal function decline.

Anonymous Patient Answer

Have there been any new discoveries for treating deteriorating renal function?

Given that the field of renal disease has been dominated by nephrologists, there are few clinicians with significant experience in treating this disease. Furthermore, most of the current treatment strategies require a combination of more than one therapeutic approach to treat worsening renal function. Current research is focused mostly on individual therapies such as ACE inhibition, glucocorticoids, and the immunosuppressive agents. Clinical trials are underway for individual therapies to determine their efficacy. But, more research and clinical trials will be needed to develop a treatment strategy for treating progressing renal function.

Anonymous Patient Answer

What is the primary cause of deteriorating renal function?

The primary cause of declining renal function was diabetic nephropathy. In a recent study, findings illustrates the value of a comprehensive evaluation of patient's co-morbidities in the initial management when nephropathy develops in non-insulin dependent diabetes.

Anonymous Patient Answer

What is tolebrutinib?

TBR treatment was associated with a high-density decline in glomerular turnover at baseline, suggestive of acute glomerular injury, despite the absence of any changes in kidney histologic abnormalities by follow-up that correlated with an associated rise in serum creatinine level. The high prevalence of renal dysfunction at this dose warrants caution when considering a broad-spectrum kinase inhibitor in the treatment setting for patients with chronic kidney disease.

Anonymous Patient Answer

How does tolebrutinib work?

There was a marked improvement in patient reported symptoms and UPCR, with tolebrutinib. This promising trial is the first to demonstrate a beneficial effect of tolebrutinib on these parameters in a patient with CLL.

Anonymous Patient Answer
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