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Kidney TransplantPhase 2TONIX-1500NCT07204080

(TNX-1500) in Kidney Transplant Recipients

A Phase 2 study testing TNX-1500 and Kidney Transplant in people with Kidney Transplant and Kidney Transplant Failure and Rejection, run by Ayman Al Jurdi, MD at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The primary objective is to investigate the safety of TNX-1500, an FC-modified anti-CD154 mAb, in five kidney transplant recipients at 12 months. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TNX-1500 and Kidney Transplant
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
2 sitesUnited States
Study dates
1 Jan 2027to 30 Nov 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects ≥18 to 75 years of age.
  • 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.
  • Recipient of an ABO-compatible, non-human leukocyte antigen (HLA) identical living or deceased donor kidney (de novo)
  • Ability to understand the study requirements and provide written informed consent.
  • Epstein-Barr virus (EBV) seropositive

Who cannot join

  • 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.
  • Recipient of a kidney from a donor who tests positive for HIV, HBsAg, Anti-HBc, or HCV NAT.
  • Subjects with a severe systemic infection, current or within the 2 weeks prior to screening.
  • Left ventricular ejection fraction < 40% as determined by TTE or clinical evidence of heart failure.
  • Any of the following ocular history or ocular findings at screening exam:
  • 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.
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  • Findings that would impact the ability to monitor, diagnose, manage, and follow new onset ocular inflammation.*
  • Receipt of ocular corticosteroids (topically, intravitreally, or periocularly) or has been treated with anti-VEGF intravitreal therapy within three months of Screening Exam
  • Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.
  • 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:
  • Female sterilization (surgical, bilateral oophorectomy with or without hysterectomy), or tubal ligation at least 6 weeks before taking study treatment.
  • 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.
  • 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.
  • Total abstinence
  • 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.
  • 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:
  • Alanine aminotransferase (ALT)
  • Aspartate aminotransferase (AST)
  • Alkaline phosphatase (ALP)
  • Bilirubin
  • Coagulation studies (international normalization ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT))
  • 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.
  • Presence of pre-existing donor-specific antibodies (DSA) or calculated panel reactive antibodies (cPRA) >20% based upon results within 6 months prior to transplant.
  • Virtual crossmatch (VXM) positive transplant with an MFI >1000 as assessed by routine methodology (Luminex)
  • Cytomegalovirus (CMV) high risk combination: donor positive to recipient negative
  • Multi-organ transplant or tissue recipient.
  • History of malignancy of any organ system, except for localized excised non-melanomatous skin or carcinoma in situ of the cervix
  • Subjects with any of the following: hemoglobin <8 mg/dL, white blood cell ≤2,000/mm3, or platelet count ≤75,000/mm3.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ayman Al Jurdi, Principal Investigator, MD contact

617-726-2000

aaljurdi@mgh.harvard.edu

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Ayman Al Jurdi, MD

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Ayman Al Jurdi, 617-726-2000, aaljurdi@mgh.harvard.edu

Other trials in United States

About this study

Official title: Phase II Clinical Trial Evaluating the Safety Efficacy of Fc-Modified Anti-CD154 mAB (TNX-1500) in Kidney Transplant Recipients

The primary objective is to investigate the safety of TNX-1500, an FC-modified anti-CD154 mAb, in five kidney transplant recipients at 12 months.

Being tested
TNX-1500, Kidney Transplant
Keywords
Kidney Transplant, New Immunosuppression
Medical subject headings
Rejection, Psychology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TNX-1500Drug

    This is an open-label, single-center, single-arm study to assess the safety of TNX-1500, an Fc-modified anti-DF154 mAb in five adult kidney transplant recipients.

  • Kidney TransplantProcedure or surgery

    Kidney Transplant

Study groups in NCT07204080
Study groupRoleWhat they receive
Kidney Transplant RecipientExperimentalNot described
Receives: Drug: TNX-1500; Procedure: Kidney Transplant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse Events in each subject

    The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at Week 76

    Measured: 76 Weeks

  2. Number of Serious Adverse Events in each subject

    The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at Week 76.

    Measured: 76 Weeks

Secondary outcomes (15)

  1. Incidence of Biopsy Proven Acute Rejection

    Acute rejection, treatment and outcome biopsy pathology grading (Banff Criteria)

    Measured: 52 Weeks

  2. Incidence of treatment for acute rejection

    Acute rejection, treatment and outcome biopsy pathology grading (Banff Criteria)

    Measured: 52 Weeks

  3. Incidence of Biopsy Proven Acute Rejection

    Acute rejection, treatment and outcome biopsy pathology grading (Banff Criteria)

    Measured: 76 Weeks

  4. Incidence of treatment for acute rejection

    Acute rejection, treatment and outcome biopsy pathology grading (Banff Criteria)

    Measured: 76 Weeks

  5. Incidence of de novo DSA development

    Measured: 52 weeks

  6. Incidence of serious opportunistic infections

    based upon AE/SAE data and available quantitative and qualitative EBV and CMV surveillance data

    Measured: 76 Weeks

  7. Incidence of malignancies

    based upon AE/SAE data and available documenting incidence of malignancy of any grade

    Measured: 76 Weeks

  8. Incidence of AEs of Special Interest

    based upon AESI/SAE data and available documenting incidence of AESI which include thromboembolic events, Infections >Grade 2, Any Grade 2 or higher injection site reactions, Any Grade 2 or higher cytokine release syndrome, ophthalmic adverse events.

    Measured: 76 Weeks

  9. GFR measurement

    Assessment of renal function through the estimated glomerular filtration rate at 12 months post-transplant

    Measured: 52 Weeks

  10. Incidence of death

    Measured: 52 Weeks

  11. Incidence of graft loss

    Measured: 52 Weeks

  12. Degree of Proteinuria

    Proteinuria by urine protein-to-creatinine ratio

    Measured: 76 Weeks

  13. Degree of albuminuria

    Albuminuria by urine microalbumin-to-creatinine ratio

    Measured: 76 Weeks

  14. GFR measurement

    Assessment of renal function through the estimated glomerular filtration rate at 12 months post-transplant

    Measured: 76 Weeks

  15. Incidence of death

    Measured: 76 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2025
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion1 Sep 2031 (estimated)
  4. Study completion30 Nov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07204080
Sponsor's protocol ID
2025P-------
Acronym
TONIX-1500
Status last verified
Nov 2026
First submitted
25 Sep 2025
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TNX-1500 and Kidney Transplant in people with Kidney Transplant and Kidney Transplant Failure and Rejection, run by Ayman Al Jurdi, MD at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ayman Al Jurdi, Principal Investigator, MD (617-726-2000, aaljurdi@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events in each subject (time frame: 76 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07204080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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