RO7795081 for Kidney Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called RO7795081 for individuals with kidney problems. The goal is to understand how this treatment behaves in the body and assess its safety across different levels of kidney function. Participants include those with normal kidney function and those with severe kidney impairments not requiring dialysis. Individuals with stable kidney issues who do not need dialysis, or those with normal kidney function, may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive it.
Is there any evidence suggesting that RO7795081 is likely to be safe for humans?
Research shows that RO7795081 remains in the early stages of testing, so limited information exists about its safety for people. In these early trials, participants took a single dose of RO7795081 orally. The studies aim to understand how the body processes the drug and to identify any side effects.
As an early-phase trial, the primary goal is to assess the safety of RO7795081. Detailed safety information from these trials is not yet publicly available. However, early-phase trials like this one involve close monitoring to ensure participant safety, with any side effects carefully observed and managed. If RO7795081 had been approved for another condition, some safety evidence would exist, but that is not the case here.
Participants should discuss potential risks and benefits with the trial team before deciding to join.12345Why do researchers think this study treatment might be promising for kidney failure?
Unlike the standard treatments for kidney failure, which often involve dialysis or kidney transplantation, RO7795081 offers a novel approach by providing a single oral dose. Researchers are excited about this treatment because it targets kidney function directly, which could lead to improved outcomes without the need for invasive procedures. Additionally, RO7795081 has the potential to work across different levels of renal impairment, from mild to severe, offering a versatile option for patients at various stages of kidney failure.
What evidence suggests that RO7795081 might be an effective treatment for kidney failure?
Researchers are conducting studies on RO7795081 to understand its effects in people with varying levels of kidney function. Participants in this trial fall into groups based on their renal function: normal, mild, moderate, or severe impairment. The main goal is to assess how the body processes the drug and to ensure its safety. While specific data on its effectiveness for kidney failure is not yet available, the study aims to gather this information. The drug's development focuses on understanding its potential benefits for individuals with kidney problems. Current trials primarily examine the drug's movement through the body and its safety for future use.23467
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for adults with normal kidney function or those with mild, moderate, or severe kidney problems (not on dialysis) whose condition is stable. Participants must be able and willing to follow study instructions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants with normal renal function and severe renal impairment receive a single oral dose of RO7795081
Treatment Part 2 (optional)
Additional participants with normal renal function and mild or moderate renal impairment may receive a single oral dose of RO7795081
Follow-up
Participants are monitored for safety and pharmacokinetics after receiving the dose
What Are the Treatments Tested in This Trial?
Interventions
- RO7795081
Trial Overview
The study tests a single oral dose of the drug RO7795081 in people with different levels of kidney function to see how their bodies process the drug and if it’s safe. Some participants may join an optional second part based on initial results.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants with mild renal impairment will receive a single oral dose of RO7795081.
Participants with moderate renal impairment will receive a single oral dose of RO7795081.
Participants with severe renal impairment or kidney failure not receiving dialysis will receive a single oral dose of RO7795081.
Participants with normal renal function will receive a single oral dose of RO7795081.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Citations
A Study Investigating the Safety of RO7795081 and ...
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) and safety of RO7795081, following a single ...
2.
genentech-clinicaltrials.com
genentech-clinicaltrials.com/en/trials/kidney-disorder/renal-failure/a-study-investigating-the-safety-of-ro7795081-and-how-t-35106.htmlClinical trial for Renal Failure, Chronic Kidney Disease-...
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) and safety of RO7795081, following a single oral dose
Treatments for Chronic Kidney Disease: A Systematic ... - PMC
Twelve trials (13.5%) reported significant reductions in the risks of composites comprising kidney failure plus one or more of doubling of serum creatinine, ...
RO7795081's Pharmacokinetics and Safety Assessment in ...
This study focuses on understanding how a drug called RO7795081 works in people with kidney problems. It's designed to compare how the body ...
Renal failure – Trials in Disease
This study is investigating whether dapagliflozin can help patients with severe chronic kidney disease (CKD) by improving both kidney and heart health outcomes.
Ask the expert - AdisInsight
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) and safety of RO7795081, ...
7.
synapse.patsnap.com
synapse.patsnap.com/blog/clinical-landscape-nct07741604-tifeglipron-trial-report-2026-mcpNCT07741604 Tifeglipron Clinical Trial Landscape 2026
... safety of RO7795081, following a single oral dose in ... renal impairment or kidney failure not receiving dialysis will receive RO7795081.
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