BridgeMD
A 12-Month Clinical Research Study to evaluate a new investigational medication (siplizumab) compared to another medication (anti thymocyte globulin) for the prevention of rejection in patients who have received a kidney transplant.
EU CTIS ID: 2023-507895-36-00
What this study is testing
To assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of siplizumab compared to rabbit anti-thymocyte globulin (rATG), in de novo renal transplant recipients over 12 months post-transplant.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Able to understand the study requirements and provide written informed consent before any study assessment is performed.
- Male or female patients ≥ 18 to 70 years of age.
- Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.
- Recipients of a kidney with a cold ischemia time (CIT) < 30 hours; hypothermic machine perfusion within the same timeframe is acceptable.
You likely can't join if
- Transplant recipients seronegative for Epstein-Barr virus (EBV).
- History of malignancy of any organ system, except for localized excised non-melanomatous skin lesions or carcinoma in situ of the cervix.
- Subjects with clinically significant laboratory abnormality that would preclude participation in the study. For example: >2.5 × upper limit of normal (ULN) values for: - Liver function chemistries (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP]) - Bilirubin - Coagulation studies (International Normalized Ratio [INR]/prothrombin time [PT], activated partial thromboplastin time [aPTT]).
- Subjects with any of the following: • Hemoglobin (Hgb) < 8 mg/dL • White blood cell (WBC) count ≤ 2,000/mm3 • Platelet count ≤ 75,000/mm3.
- Seropositive for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg). Subjects who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment.
- Recipient of a kidney from a donor who tests positive for HIV, HBsAg/hepatitis B core antigen (HBcAg) positive or HCV.
See the full eligibility criteria
Who can join
- Able to understand the study requirements and provide written informed consent before any study assessment is performed.
- Male or female patients ≥ 18 to 70 years of age.
- Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.
- Recipients of a kidney with a cold ischemia time (CIT) < 30 hours; hypothermic machine perfusion within the same timeframe is acceptable.
What rules you out
- Transplant recipients seronegative for Epstein-Barr virus (EBV).
- History of malignancy of any organ system, except for localized excised non-melanomatous skin lesions or carcinoma in situ of the cervix.
- Subjects with clinically significant laboratory abnormality that would preclude participation in the study. For example: >2.5 × upper limit of normal (ULN) values for: - Liver function chemistries (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP]) - Bilirubin - Coagulation studies (International Normalized Ratio [INR]/prothrombin time [PT], activated partial thromboplastin time [aPTT]).
- Subjects with any of the following: • Hemoglobin (Hgb) < 8 mg/dL • White blood cell (WBC) count ≤ 2,000/mm3 • Platelet count ≤ 75,000/mm3.
- Seropositive for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg). Subjects who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment.
- Recipient of a kidney from a donor who tests positive for HIV, HBsAg/hepatitis B core antigen (HBcAg) positive or HCV.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g., siplizumab, anti-thymocyte globulin [ATG], tacrolimus [TAC], mycophenolate mofetil [MMF], corticosteroifs [CS]).
- Any additional contraindication to the use of TAC or MMF according to the national labeling information of these products (refer to the local product label).
- Evidence of tuberculosis (TB) infection (after anti-TB treatment, patients with history of latent TB may become eligible according to national guidelines).
- Subjects with severe systemic infections, current or within the two weeks prior to randomization.
- Subjects with any other clinically significant medical condition, active infection or laboratory abnormality that would, in the judgment of the Investigator, interfere with the subject’s ability to participate in the study.
- Multi-organ transplant recipients.
- Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.
- Use of other investigational products or enrollment in another investigational drug study within 30 days of screening or 5 half-lives of the medication, whichever is longer.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 24 weeks after the study medications have been stopped. Highly effective contraception methods include: Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject. Any of the following: Use of oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%); for example, hormone vaginal ring or transdermal hormone contraception. Placement of long-acting reversible contraceptives, an intrauterine device, or intrauterine system. In case of use of oral contraception, women should have been stable on the same brand (or generic equivalent) for a minimum of 3 months before taking study treatment. Additionally, total abstinence, when in line with the preferred and usual lifestyle of the subject, may be an acceptable form of contraception. Withdrawal and period abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable forms of contraception. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment if she is considered not of childbearing potential.
- Subjects who have received a kidney allograft previously (e.g. re-transplant).
- Recipient of a kidney from an HLA identical living related donor
- Recipient of a kidney from a donor after cardiac death
- Subjects at high immunological risk for rejection as determined by local practice (e.g., presence of pre-existing donor-specific antibodies [DSA], recipient of high Kidney Donor Profile Index ≥ 85 kidney (where assessed).
- Subjects with anti-HLA donor specific antibody as measured by complement-dependent cytotoxicity (CDC) assay, enzyme-linked immunosorbent assay (ELISA), or flow cytometry within 90 days prior to transplant or as performed per the center's local practice.
- Complement-dependent cytotoxicity (CDC) crossmatch positive transplant (isolated positive B cell crossmatches are not an exclusion criterion).
- ABO incompatible recipient
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.