Cure My Disease

Don't miss your cure!

 Log in / Sign up

New Two-Step therapy aims to stop chronic kidney transplant rejection

NCT ID NCT07718308

Disease control Sponsor: wujianyong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study tests a new treatment for chronic active antibody-mediated rejection (caABMR) in kidney transplant recipients. Patients receive a single injection of a CD38 monoclonal antibody to deplete harmful immune cells, followed by long-term azathioprine pills to maintain control. The goal is to slow or stop the decline in kidney function. Twenty participants across six centers in China will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a CD38 monoclonal antibody (single injection) followed by azathioprine pills
What this could lead to
If successful, this approach could offer a new way to treat chronic rejection in kidney transplant patients, potentially preserving kidney function longer without needing stronger lifelong immune suppression.
What could go wrong
This is a small, early exploratory study with only 20 participants, so results may not apply broadly. The treatment carries risks from immune suppression, including infection and possible side effects from the antibody.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntary written informed consent. 2. Age ≥18 years. 3. Kidney transplant (living or deceased donor) ≥180 days prior. 4. eGFR ≥30 mL/min/1.73 m² (CKD-EPI 2021). 5. Currently on stable triple immunosuppression (CNI + MMF + steroid) for ≥4 weeks, no severe related adverse effects. 6. Positive HLA Class I and/or Class II donor-specific antibodies (DSA). 7. Transplant kidney biopsy meeting Banff 2022 criteria for chronic active antibody-mediated rejection (caABMR). 8. TPMT/NUDT15 genotyping: non-homozygous mutant (normal or intermediate metabolizer). Exclusion Criteria: 1. Participating in another clinical trial. 2. Age \<18 years. 3. Pregnant, breastfeeding, or inadequate contraception in females. 4. ABO-incompatible transplant. 5. TPMT/NUDT15 homozygous mutant genotype. 6. Biopsy shows any of: T-cell mediated rejection (TCMR), new/recurrent severe thrombotic microangiopathy, or polyomavirus nephropathy. 7. Received anti-rejection therapy in prior 3 months. 8. Received other immunomodulatory monoclonal/polyclonal antibodies (anti-CD20, bortezomib, anti-C5, anti-IL-6/IL-6R) in prior 3 months. 9. Total bilirubin \>2×ULN or ALT/AST \>2.5×ULN. 10. Hemoglobin \<8 g/dL. 11. Platelets \<100×10\^9/L. 12. WBC \<3×10\^9/L or neutrophils \<1.5×10\^9/L. 13. Hypogammaglobulinemia: IgG \<400 mg/dL. 14. Active bacterial, viral, or fungal infection. 15. Active malignancy requiring intensified immunosuppression. 16. Latent or active tuberculosis. 17. Live vaccine within 6 weeks of screening. 18. History of alcohol or illicit drug abuse. 19. Severe medical or psychiatric illness likely to impair study participation. 20. Active hepatitis B. 21. Known hypersensitivity to CD38 mAb, azathioprine, or study drug components, or severe drug allergy history.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Antibody-mediated rejection are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

acute transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antibody-mediated rejection Kidney transplantation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.