New drug aims to stop kidney rejection
NCT ID NCT07204080
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This early study tests a new medicine called TNX-1500 in 5 people who get a kidney transplant. The goal is to see if it is safe and can help prevent the body from rejecting the new kidney. Participants will be followed for one year to check for side effects and signs of rejection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female subjects ≥18 to 75 years of age. 2. Kidney transplant candidates with chronic kidney disease (stage IV or V) or end-stage kidney disease evaluated and listed for transplantation at Massachusetts General Hospital. 3. Recipient of an ABO-compatible, non-human leukocyte antigen (HLA) identical living or deceased donor kidney (de novo) 4. Ability to understand the study requirements and provide written informed consent. 5. Epstein-Barr virus (EBV) seropositive Exclusion Criteria: 1. Recipient seropositive for human immunodeficiency virus (HIV-1), or hepatitis B surface antigen (HBsAg) or core antibody (Anti-HBc); subjects who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment or spontaneous clearance. 2. Recipient of a kidney from a donor who tests positive for HIV, HBsAg, Anti-HBc, or HCV NAT. 3. Subjects with a severe systemic infection, current or within the 2 weeks prior to screening. 4. Left ventricular ejection fraction \< 40% as determined by TTE or clinical evidence of heart failure. 5. Any of the following ocular history or ocular findings at screening exam: 1. Active inflammation in either or both eyes (does not include pigment cell in the AC after dilation); must be greater than trace cell or trace flare to exclude. 2. Findings that would impact the ability to monitor, diagnose, manage, and follow new onset ocular inflammation. 3. Receipt of ocular corticosteroids (topically, intravitreally, or periocularly) or has been treated with anti-VEGF intravitreal therapy within three months of Screening Exam 6. Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test. 7. Women of childbearing potential (women capable of becoming pregnant) unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Highly effective contraception methods include: 1. Female sterilization (surgical, bilateral oophorectomy with or without hysterectomy), or tubal ligation at least 6 weeks before taking study treatment. 2. Male sterilization (at least 6 months prior to screening); for female subjects on the study, the vasectomized male partners should be the sole partners for that subject. 3. Use of injected or implanted hormonal methods of contraception or other hormonal contraception that have comparable efficacy (\<1% for example, hormone vaginal ring or placement of a long-acting reversible contraceptives, an intrauterine device, or intrauterine system. 4. Total abstinence 8. Use of other investigational products or enrollment in another investigational drug study within 30 days prior to screening or 5 half-lives, whichever is longer. 9. Subjects with clinically significant lab abnormalities (\>2.5 x the upper limit of normal (ULN) of the following liver function chemistries unless due to, as judged by the investigator, a benign underlying condition: 1. Alanine aminotransferase (ALT) 2. Aspartate aminotransferase (AST) 3. Alkaline phosphatase (ALP) 4. Bilirubin 5. Coagulation studies (international normalization ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT)) 10. Any other clinically significant medical condition, active infection, laboratory abnormality, or psychosocial condition (e.g. history of substance use disorder) that would, in the judgement of the investigator, impact the subject's ability to participate in the trial. 11. Presence of pre-existing donor-specific antibodies (DSA) or calculated panel reactive antibodies (cPRA) \>20% based upon results within 6 months prior to transplant. 12. Virtual crossmatch (VXM) positive transplant with an MFI \>1000 as assessed by routine methodology (Luminex) 13. Cytomegalovirus (CMV) high risk combination: donor positive to recipient negative 14. Multi-organ transplant or tissue recipient. 15. History of malignancy of any organ system, except for localized excised non-melanomatous skin or carcinoma in situ of the cervix 16. Subjects with any of the following: hemoglobin \<8 mg/dL, white blood cell ≤2,000/mm3, or platelet count ≤75,000/mm3.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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