Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease (NCT06071143) | Clinical Trial Compass
CompletedPhase 1
Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease
South Korea6 participantsStarted 2024-02-29
Plain-language summary
A Single arm, Open-labelled, Dose-escalation, Single-center, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Autologous Urine-derived Stem Cells, 『KDSTEM Inj.』, in Patients with Chronic Kidney Disease.
The aim of this study is to evaluate the safety and preliminary efficacy of KDSTEM Inj. in the treatment in Patients with Chronic Kidney Disease.
Who can participate
Age range
19 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female aged between 19 and 80 at the time of signing the agreement
. Chronic kidney disease patients with an eGFR of 20 to 59 ml/min/1.73m² by MDRD at the screening and baseline
. Male or female of childbearing age agreed to use accurate birth control method during this clinical trial
. Subjects voluntarily signed an agreement in writing for this clinical trial
Exclusion criteria
. Subjects who meet any of the following conditions at the screening visit
. Systemic infection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial, which means it was primarily designed to test safety rather than prove the treatment works — does the data collected so far tell us anything useful about whether KDSTEM actually helps slow down or improve chronic kidney disease?
2Since this trial has already completed and was measuring treatment-related adverse events using a formal safety scale, has any of that safety data been published or shared, and what kinds of side effects showed up in participants?
3KDSTEM appears to be an injectable stem cell or cell-based therapy — how does that approach compare to the standard treatments you'd recommend for my stage of chronic kidney disease right now?
4Because this was a Phase 1 study with a completed status, would there be a follow-up Phase 2 trial I could potentially discuss with you, or would you suggest sticking with established treatments given how early this research still is?
5Given that this trial is finished and no longer enrolling, what would you recommend as my next step — are there other active trials for chronic kidney disease that you think might be worth looking into together?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
Timeframe: 28 weeks follow-up after first injection