Can a new infusion stop the Body's attack on a transplanted kidney?
NCT ID NCT07764627
First seen Aug 14, 2026 · Last updated Aug 18, 2026 · Updated 2 times
Summary
This trial tests an experimental drug called SG301 in people who have antibody-mediated rejection after a kidney transplant. The goal is to see if the drug is safe and may help control the immune system's attack on the new kidney. Participants receive the drug by infusion weekly for a month, then every four weeks for about a year. The study focuses on safety and how well the drug works in this specific group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SG301 injection, an experimental drug given by intravenous infusion
- What this could lead to
- If successful, this could offer a new treatment option to control antibody-mediated rejection and help preserve kidney function in transplant recipients.
- What could go wrong
- This is a small, early-phase trial with only 10 participants, so results may not apply broadly. The drug may cause side effects or fail to improve 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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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. Voluntarily sign the written informed consent form; 2. Age ≥18 and ≤75 years; 3. Expected survival ≥3 months; 4. ≥180 days after renal transplantation, with stable graft function (from living or deceased donor); 5. Biopsy-confirmed active or chronic active AMR (with or without peritubular capillary C4d deposition), per Banff 2022 classification; 6. DSA: within 6 months prior to first dose, donor specific antibodies (DSA) specific to HLA class I and/or II antigens (pre existing and/or de novo) confirmed by local laboratory and meeting the local laboratory's positive definition; 7. Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m² at screening (CKD EPI formula); 8. Recovery from adverse events due to prior treatment to ≤ Grade 1 (CTCAE v6.0), except for toxicities such as alopecia that are judged by the investigator to have no safety risk and not to violate other inclusion/exclusion criteria; 9. Female participants of childbearing potential or male participants whose partners are of childbearing potential must remain abstinent or use reliable contraceptive measures during the study treatment period and for at least 6 months after the last dose of SG301. Male participants must refrain from sperm donation during the study and for at least 6 months after the last dose. Exclusion Criteria: 1. Concomitant T cell-mediated rejection (TCMR); 2. New-onset or recurrent severe thrombotic microangiopathy; polyomavirus nephropathy; new-onset or recurrent glomerulonephritis; 3. Prior treatment with other anti-CD38 monoclonal antibodies; 4. Use of other monoclonal/polyclonal antibody immunosuppressive agents within 3 months prior to the first dose of study drug; 5. Latent or active tuberculosis, or active viral (HBV, HCV, HIV, CMV), bacterial, or fungal infection requiring systemic therapy, or other active infections requiring systemic treatment; 6. Active malignancy that makes the patient unsuitable for immunosuppressive therapy; 7. Presence of serious medical or psychiatric illness that may interfere with the smooth conduct of the study; 8. Prior multi-organ transplantation (including en bloc or dual kidney transplantation); 9. Acute, rapid decline in renal function such that, in the investigator's judgement, the participant is likely to require renal replacement therapy within the subsequent 30 days; 10. Receipt of any of the following treatments for AMR or TCMR within 3 months prior to the first dose of study drug (with the exception of glucocorticoids): 1. Intravenous or subcutaneous immunoglobulin (IVIg/SCIg), plasma exchange, or immunoadsorption (antibody-depleting therapies); 2. Complement system inhibitors (e.g., eculizumab); 3. Proteasome inhibitors (e.g., bortezomib); 4. Tocilizumab; 5. Other investigational drugs within 3 months or 5 half-lives (whichever is longer) prior to start of study treatment; 11. Female participants who are pregnant or breastfeeding; 12. Other conditions that, in the investigator's judgement, would make the participant unsuitable for participation in the study.
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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
7 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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First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
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Shulan(Hang Zhou) Hospital
Hangzhou, Zhejiang, China
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The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, 250012, China
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510062, China
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The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530006, China
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The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
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West China Hospital,Sichuan University
Chengdu, Sichuan, 610044, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New Two-Step therapy aims to stop chronic kidney transplant rejection
- Gene expression platform could revolutionize kidney transplant rejection diagnosis
- New drug aims to stop kidney transplant rejection
- New hope for kidney transplant patients: extended drug trial targets rejection
- Gene clues may explain why light therapy helps some transplant patients