Is NCT06741072 recruiting in Columbus, OH?

Yes, NCT06741072 is currently recruiting participants at its Columbus, OH location. This chronic kidney disease, stage 4 clinical trial is actively enrolling qualified participants.

How do I join the chronic kidney disease, stage 4 clinical trial in Columbus?

To join this clinical trial in Columbus, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Columbus clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chronic Kidney Disease, Stage 4 Clinical Trial in Columbus, OH

About This Chronic Kidney Disease, Stage 4 Study in Columbus

This phase 1B trial tests the safety, side effects and best dose of rh-Hsc70- BZLF1 peptide complex (OSU-2131) with Stimulon (Trademark) QS-21 and evaluates how well it works in preventing Epstein-Barr virus (EBV) infection and related cancers in healthy volunteers and patients awaiting a solid organ transplant. Currently, patients who receive an organ transplant receive immune suppression therapy which can make it harder for the body to fight infections. This treatment also increases the risk for cancers that are triggered by the EBV. Vaccines made from synthetic peptide (RAKFKQLL) derived from the BZLF1 protein, may help the body build an effective immune response against EBV infections. QS-21, a saponin adjuvant, is a substance from plants that, when given with vaccine therapy, may improve the way the immune system responds to disease. Giving OSU-2131 with QS-21 may help the immune system fight EBV and protect against EBV infection and the cancers that it can cause in patients awaiting solid organ transplants.

Sponsor: Ohio State University Comprehensive Cancer Center

Who Can Participate

Inclusion Criteria

Healthy volunteers and patients awaiting solid organ transplantation (SOT) must have at least one allele for HLA-B\*08:01

Subjects can be Epstein-Barr virus (EBV) seronegative or seropositive

Subjects must be seronegative for HIV

Subjects must be seronegative for hepatitis B and C

Have baseline chemistry and hematology (hemoglobin, white blood cells, absolute neutrophil count, eosinophils) within normal limits

Prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal

Platelets above the lower limit of normal (LLN)

Basophils, lymphocytes, and monocytes must be within 1.2 x upper limit of normal (ULN) or 0.8 x LLN and considered not clinically significant by the investigator

Total creatine kinase (CK) laboratory values \< 1.25 x the upper limit of normal (according to the normal reference ranges of the Ohio State University \[OSU\] laboratory) at baseline (screening \& pre-study visit) and considered not clinically significant by the investigator

Subjects must not be taking antiviral therapy

Must be ≥ 18 years of age and ≤ 65 years of age and willing to either use an effective method of contraception or abstain from sexual activity for at least 3 months following the last dose of vaccination

Female of childbearing potential must have a negative serum pregnancy test prior to the first study drug/placebo (PBS) administration

Agree not to receive any other investigational drug while enrolled in this study

Provide written informed consent according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and local regulations

Following successful completion of safety evaluation for the phase 1 dose escalation phase of this trial in healthy volunteers and review of this data by the Sponsor and Food and Drug Administration (FDA), we plan to enroll a second cohort of patients awaiting solid organ transplantation (SOT). We will recruit patients with end stage renal disease (ESRD) who are awaiting kidney transplantation. ESRD is defined according to 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease (Acosta-Ochoa et al, J Clin Med, 8(9):1323, 2019). KDIGO defines ESRD as: stage 4: severe reduction in glomerular filtration rate (GFR) (15 to 29 mL/min); stage 5: renal failure (GFR less than 15 mL/min). Patients will qualify for ESRD / kidney transplantation per need for maintenance dialysis due to one or more of the criteria related to renal insufficiency: volume overload, metabolic acidosis, electrolyte disturbance, drug toxicity, etc. Patients will be regularly undergoing hemodialysis or peritoneal dialysis for metabolic support. Patients will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes

Exclusion Criteria

Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion

History of chronic active EBV infection, active infectious mononucleosis (or infectious mononucleosis within 6 months of enrollment), or other EBV-related disorder as determined by principal investigator (PI)

History of immune suppression or autoimmune disorder

Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable

Pregnant or breastfeeding subjects

For patient enrollment on the second cohort, "patients awaiting SOT", we will consider patients awaiting kidney transplantation who are receiving maintenance renal replacement therapy (dialysis). Most patients on routine renal replacement therapy (dialysis) will present with stable chemistry, acid base balance, volume status and clear mental status. For patients who are non-compliant with routine dialysis, laboratory abnormalities and acid base, volume status can become abnormal. Specific dose limiting toxicity (DLT) criteria that may relate to patients with ESRD include laboratory parameters that may altered due to missed dialysis session(s). Most laboratory abnormalities in such patients can be corrected by restarting dialysis or blood transfusions. Outside these specific variables, we do not expect to see specific DLT criteria for patients with ESRD on this study. Metabolic derangement such as acid base imbalance, hyperkalemia and volume overload as a result of missing dialysis session. Study stopping rule for subjects awaiting organ transplant: Occurrence of this event in two or more subjects should result in study pause. Patients who are unable to adhere to routine dialysis will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Columbus?

Yes, this clinical trial (NCT06741072) has an active research site in Columbus, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Kidney Disease, Stage 4 Treatment Options in Columbus, OH

If you're searching for chronic kidney disease, stage 4 treatment options in Columbus, OH, this clinical trial (NCT06741072) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Columbus research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced chronic kidney disease, stage 4 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic kidney disease, stage 4 clinical trials near you to find additional studies recruiting in your area.

Chronic Kidney Disease, Stage 4 Clinical Trial in Columbus, OH

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