End Stage Renal Disease study: Ribupatide
Official title A Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics (PK) of Ribupatide
ClinicalTrials.gov ID: NCT07793929
What this study is testing
What is Ribupatide?
An investigational subcutaneous injection being studied for patients with end‑stage renal disease.
Also referred to as KAI‑9531.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To measure how ribupatide behaves in the body of people with severe kidney problems compared to those with normal kidney function.
- Who it's for
- Adults with severe kidney impairment or end‑stage kidney disease.
- What's involved
- Participants receive one subcutaneous injection of ribupatide and have blood samples taken to track the drug’s levels.
- Time commitment
- The study lasts one day with a single injection and blood draws; no additional visits are required.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Body mass index ≥18.5 at Screening.
- Female Participants: Must not be pregnant or planning to be pregnant or breastfeeding or planning to breastfeed during the study and for at least 35...
- Female participants: Must have a negative serum pregnancy test at Screening.
- Suitable venous access for blood sampling.
You likely can't join if
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic...
- Abnormal thyroid-stimulating hormone at Screening.
- Any history of malignant disease including in situ cervical or prostate cancer within the last 5 years.
- History of or positive test results at the Screening Visit for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or active hepatitis...
- Participated in another clinical study of a study drug or investigational device within 30 days or 5 half-lives of the study drug (whichever is...
- Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic...
See the full eligibility criteria
- Body mass index ≥18.5 at Screening.
- Female Participants: Must not be pregnant or planning to be pregnant or breastfeeding or planning to breastfeed during the study and for at least 35 days after the study drug dose.
- Female participants: Must have a negative serum pregnancy test at Screening.
- Suitable venous access for blood sampling.
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including...
- Abnormal thyroid-stimulating hormone at Screening.
- Any history of malignant disease including in situ cervical or prostate cancer within the last 5 years.
- History of or positive test results at the Screening Visit for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or active hepatitis C virus (HCV) infection.
- Participated in another clinical study of a study drug or investigational device within 30 days or 5 half-lives of the study drug (whichever is longer) prior to Screening.
- Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist, or glucagon receptor agonist within 3...
- Known hypersensitivity to the study drug, glucagon-like peptide-1 (GLP-1) therapies, or any of the study drug ingredients.
- Received any vaccinations within 30 days prior to Screening.
- Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic, or antiviral medication within 10 days prior to the dose of study drug.
The study team makes the final eligibility decision.
Where it is enrolling
- Orlando, Florida, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Orlando, Florida, United States; San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.