CLINICAL TRIAL

sparsentan for Kidney Diseases

Waitlist Available · 18+ · All Sexes · Dallas, TX

This study is evaluating whether a drug may help prevent kidney disease in patients with IgA nephropathy.

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About the trial for Kidney Diseases

Eligible Conditions
Kidney Diseases · Glomerulonephritis, IGA · Immunoglobulin A Nephropathy

Treatment Groups

This trial involves 2 different treatments. Sparsentan 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.
sparsentan
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
irbesartan
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (maximum tolerated dose and at least one-half of the maximum labeled dose)
Willing to undergo change in ACEI and/or ARB and anti-hypertensive medications
Age 18 years or older at screening
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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: Week 110 postrandomization
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 110 postrandomization.
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 sparsentan will improve 1 primary outcome and 3 secondary outcomes in patients with Kidney Diseases. Measurement will happen over the course of After the last patient randomized has undergone the Week 36 visit.

Urine protein/creatinine ratio (UP/C) at Week 36
AFTER THE LAST PATIENT RANDOMIZED HAS UNDERGONE THE WEEK 36 VISIT
The primary efficacy endpoint is the change from baseline (Day 1) in the UP/C based on a 24-hour urine sample at Week 36.
eGFR over a 52-week period
WEEK 58 POSTRANDOMIZATION
The rate of change in estimated glomerular filtration rate (eGFR) over a 52-week period following the initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks postrandomization to 58 weeks postrandomization eGFR chronic slope at 1 year.)
eGFR over a 110-week period
WEEK 110 POSTRANDOMIZATION
The rate of change in eGFR over a 110-week (approximately 2 years) period following the initiation of randomized therapy (thus, the analysis is from Day 1 to 110 weeks postrandomization eGFR total slope at 2 years).
eGFR over a 104-week period
WEEK 110 POSTRANDOMIZATION
The rate of change in estimated glomerular filtration rate (eGFR) over a 104-week period following initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks postrandomization to 110 weeks postrandomization eGFR chronic slope at 2 years.)

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 kidney diseases be cured?

There has not been enough scientific evidence that CKD can be cured. However, kidney donors should be informed that, although some kidney diseases can be cured, others cannot.

Anonymous Patient Answer

What causes kidney diseases?

Diseases of the kidneys begin earlier in life when the kidneys have not matured properly, a condition known as congenital nephropathy. Most kidney diseases occur after young adults become disabled or die from accidents or injuries. Congenital nephropathy does progress later. Congenital nephropathy and other hereditary diseases are hereditary disorders that arise with a defect in the structure and/or operation of one or more parts of the kidney. Other kidney diseases may occur because of infection from bacteria or parasites such as toxoplasmosis, malaria, or trypanosomiasis. Diabetes mellitus is a type of kidney disease, but the disease does not originate in the kidneys.

Anonymous Patient Answer

What is kidney diseases?

The average prevalence of kidney diseases is about 30%. Kidney diseases have been growing in industrialized countries over the last decades and have been associated with an increasing prevalence of other chronic noncommunicable diseases (CNCDs).

Anonymous Patient Answer

What are the signs of kidney diseases?

Signs and symptoms related to kidney diseases include fatigue, lack of energy, weight loss, feeling unwell, frequent vomiting and abdominal pain. Other symptoms that are uncommon include blood in the urine, blood on the urine pad, and joint or muscle pains. Patients with kidney diseases may also have impaired coagulation. Patients should be advised of the signs and symptoms of kidney problems; they should be kept under routine assessment.

Anonymous Patient Answer

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

Approximately 5.6 million people get kidney diseases a year, which leads to 13,500 deaths in the United States. The leading cause of death in CKD patients is cardiovascular disease, which is due to the increased propensity of CKD to exacerbate atherosclerosis and hypertension, and the increased risk of ischemia and ischemic heart disease.

Anonymous Patient Answer

What are common treatments for kidney diseases?

This paper presents an overview of medicines used worldwide in routine treatment. In each group examined, medicines are widely used, and this would appear to reflect the need or recommendation for medicines. This paper also presents a review of treatments and their relative frequencies. This information may be useful in clinical decision-making for patients and carers.

Anonymous Patient Answer

What is the primary cause of kidney diseases?

Chronic kidney diseases are caused by many agents and these are not categorized as a single disease entity in the global literature. The present study revealed that kidney diseases are multifactorial diseases in which the specific etiologic exposures are still unknown for many of the diseases; more research in this direction is needed to arrive at a solid, universally accepted definition for this syndrome.

Anonymous Patient Answer

What are the latest developments in sparsentan for therapeutic use?

As there are no approved treatments for kidney, liver or lung disease, we still can not provide a very accurate prediction of treatment response in kidney, liver and lung diseases based on our knowledge of AT1 receptor signaling. Moreover, the limited sample size in clinical trials is still a serious issue. In order to shorten the duration of current clinical trials and hopefully improve the prognosis of patients with kidney disease, it is important to use more participants. We need to know more about kidney cancer.

Anonymous Patient Answer

Has sparsentan proven to be more effective than a placebo?

The findings of the current investigation demonstrate the effectiveness of sparsentan in two doses (10 mg and 20 mg) in reducing PVR. The study further demonstrated how sparsentan provided significant improvements to the symptoms of patients with CHF and PAH.

Anonymous Patient Answer

Is sparsentan safe for people?

The evidence suggests that sparsentan is likely to be safe and effective for people with NSF-V in this real-life setting and at the dosage and duration investigated in the clinical trial.

Anonymous Patient Answer

Have there been any new discoveries for treating kidney diseases?

There have been several successes and failures in treating renal disease with new drugs or new forms of treatment. While the number of drug and treatment options available to patients with kidney disease is expanding, the quality of care still lags behind and there is an inordinately high rate of mortality with kidney diseases. Future research should focus on optimizing nephrology care for patients with kidney disease.

Anonymous Patient Answer

Does kidney diseases run in families?

Even though the family history of kidney diseases might play a role in the pathogenesis of kidney diseases, genetic studies fail to establish a causal link.

Anonymous Patient Answer
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