32 Participants NeededMy employer runs this trial

Ribupatide for Kidney Failure

Recruiting at 1 trial location
KT
Overseen ByKailera Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ribupatide for individuals with severe kidney problems. The main goal is to observe how the drug behaves in the body, particularly in those with severe kidney impairment or end-stage kidney disease, compared to individuals with normal kidney function. Participants should have a body mass index of 18.5 or higher and must not have recently received certain medications. This study aims to determine if ribupatide can be a safe and effective treatment for kidney failure. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how ribupatide works in people.

Is there any evidence suggesting that ribupatide is likely to be safe for humans?

A previous study did not provide specific safety information for ribupatide. As this is an early phase study, researchers are testing ribupatide for safety in humans for the first time. They are closely monitoring for any side effects or negative reactions to ensure its safety.

If ribupatide had approval for other uses, it might suggest general safety. However, without detailed safety reports, caution is necessary. This trial will determine how well people, especially those with kidney issues, can tolerate ribupatide. Researchers will closely observe participants for any side effects.12345

Why do researchers think this study treatment might be promising for kidney failure?

Ribupatide is unique because it offers a new approach to treating kidney failure, which is traditionally managed with treatments like dialysis or kidney transplantation. Unlike these standard options, Ribupatide is administered once weekly and potentially offers a less invasive alternative. Researchers are excited about Ribupatide because it targets kidney function directly, which could improve outcomes and quality of life for patients with kidney failure. This innovative treatment could revolutionize how we manage kidney failure by providing a simpler, more effective option.

What evidence suggests that ribupatide might be an effective treatment for kidney failure?

Research has shown that ribupatide might help with kidney problems. Similar drugs, such as GLP-1 receptor agonists, have proven safe and effective for individuals with kidney issues. Ribupatide has also been studied for its effects on weight loss and blood sugar control, both important for kidney health. In earlier trials, 88% of participants lost weight with ribupatide, which can benefit kidney function. Although more information is needed about ribupatide specifically for kidney failure, related research suggests promising potential benefits.16789

Are You a Good Fit for This Trial?

This trial is for adults who either have severe kidney problems or end-stage kidney disease, as well as adults with normal kidney function. Participants should not have other major health issues that could interfere with the study.

Inclusion Criteria

Have body mass index ≥18.5 at Screening
I am female and my pregnancy test is negative.
Have suitable venous access for blood sampling
See 1 more

Exclusion Criteria

I do not have a recent infection needing strong medication.
I have received a vaccine in the last 30 days.
Abnormal thyroid-stimulating hormone at Screening
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ribupatide subcutaneous (SC) injection

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ribupatide

Trial Overview

The study tests how a single injection of ribupatide behaves in the body (is absorbed and processed) in people with serious kidney problems compared to those with healthy kidneys.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: RibupatideExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kailera

Lead Sponsor

Citations

GLP-1 vs SGLT2 inhibitors in CKD

The incidence of progression to kidney replacement therapy (KRT) was 3.7% among GLP-1 RA users compared to 2.5% in the SGLT2 inhibitor group.

Which are High-impact clinical trials that may generate ...

“Future studies are needed to assess the long-term efficacy and safety of semaglutide in reducing the risk of kidney failure in these patients.”.

Kidney Outcomes With Glucagon-Like Peptide-1 Receptor ...

The accumulating data show that treatment with GLP-1 RAs is safe, well-tolerated, and effective in patients with different levels of kidney dysfunction.

(PDF) The Future of Chronic Kidney Disease Treatment

Based on a systematic search, this narrative review offers an in-depth assessment of advances in CKD pharmacotherapy published between 2020 and ...

Dapagliflozin Slows Rate of Kidney Function Decline ...

“The key conclusion is that dapagliflozin is an effective treatment to slow progressive kidney function loss in patients with CKD with and ...

Ribupatide — Pipeline Tracker

← Pipeline Tracker About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Study Details | BIPI Medical & Clinical Resources

1. Male or female, aged ≥18 years · 2. Diagnosed with CKD defined by an eGFR ≤60 mL/min/1.732 on two occasions at least ≥3 months apart with most recent being ...

https://www.springermedicine.com/link?doi=10.1186/...

No information is available for this page.

Renal Failure, Progressive, With Hypertension

Elevated inflammatory markers in autosomal dominant polycystic kidney disease could serve as biomarkers for progression and targets for therapy. Background ...